An Open-Label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC).
The participants will be treated with vedolizumab for up to 34 weeks.
During the study, participants will visit their study clinic several times.

Start Date31 Jan 2025

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

IRCT20150303021315N33 / SuspendedPhase 3

A phase III, randomized, two-armed, double-blind, parallel, active-controlled, non-inferiority clinical trial to compare efficacy and safety of Vedolizumab (AryoGen) versus Vedolizumab (Entyvio®, Takeda Inc.) in patients with moderate-to-severe Ulcerative Colitis between 18 to 75 years

Start Date26 Jan 2025

Sponsor / Collaborator

Aryogen Pharmed

NCT06581328 / Not yet recruitingPhase 4

A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission).
Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab.
During the study, participants will visit their study clinic several times.

Start Date15 Jan 2025

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

100 Clinical Results associated with Vedolizumab

100 Translational Medicine associated with Vedolizumab

100 Patents (Medical) associated with Vedolizumab

1,929

Literatures (Medical) associated with Vedolizumab

01 Jan 2025·Lancet Gastroenterology & Hepatology

Vedolizumab prophylaxis against postoperative Crohn's disease recurrence

Article

Author: Mulligan, Robert J ; Lamb, Christopher A

01 Jan 2025·EUROPEAN JOURNAL OF GASTROENTEROLOGY & HEPATOLOGY

Systematic review with meta-analysis of the effectiveness of subcutaneous biologics versus intravenous biologics in inflammatory bowel diseases

Review

Author: Heldt, Rishni ; Kamal, Shahed ; Elford, Alexander T. ; Segal, Jonathan P. ; Christensen, Britt

Background:

Biologic therapies are commonly used for inflammatory bowel disease (IBD) patients. Multiple biologic medicines can now be given both intravenously and subcutaneously. The different administration routes present provide different advantages regarding dose escalation, healthcare resource utilisation, pharmacokinetics, convenience and safety. Comparator effectiveness studies between intravenous and subcutaneous administration are lacking.

Aim:

Our primary outcome was to compare the effectiveness between intravenous and subcutaneous biologics in rates of clinical remission.

Methods:

We performed a systematic review and meta-analysis to include all relevant articles from MEDLINE (Ovid), EMBASE, PubMed and Cochrane Central Register of Controlled Trials from 1 January 2003 to 28 January 2024. Studies that compared intravenous and subcutaneous administration of the same biologic therapy in IBD patients and reported effectiveness outcomes were included. This study was registered on PROSPERO (CRD42023442675).

Results:

Twenty studies met the inclusion criteria for the systematic review. Nine vedolizumab cohort studies were meta-analysed for clinical remission and no difference was found in clinical remission rates between intravenous and subcutaneous administration (relative risk = 0.99; 95% confidence interval: 0.88, 1.11). Six infliximab cohort studies were meta-analysed for clinical remission and no difference was found in clinical remission rates between intravenous and subcutaneous administration (relative risk = 0.91; 95% confidence interval: 0.77, 1.08).

Conclusions:

Our findings in the first meta-analysis comparing the effectiveness of intravenous and subcutaneous biologic therapies in IBD suggest there is no difference in the effectiveness between these two administration routes. However, further high-quality studies, particularly head-to-head studies are needed to confirm this finding.

01 Jan 2025·Lancet Gastroenterology & Hepatology

Vedolizumab to prevent postoperative recurrence of Crohn's disease (REPREVIO): a multicentre, double-blind, randomised, placebo-controlled trial

Article

Author: Lopez-Sanroman, Antonio ; Gecse, Krisztina B ; Roblin, Xavier ; Taxonera, Carlos ; Laharie, David ; West, Rachel ; Mookhoek, Aart ; Nos, Pilar ; D'Haens, Geert ; Bouhnik, Yoram ; Zou, Guangyong ; Clasquin, Esmé ; Oldenburg, Lotte ; Mares, Wout G N ; Armuzzi, Alessandro ; Danese, Silvio ; Feagan, Brian G ; Hulshoff, Melanie S ; Duijvestein, Marjolijn ; Peyrin-Biroulet, Laurent

BACKGROUND:

Approximately half of patients with Crohn's disease require ileocolonic resection. Of these, 50% will subsequently have endoscopic disease recurrence within 1 year. We aimed to evaluate the efficacy and safety of vedolizumab to prevent postoperative recurrence of Crohn's disease.

METHODS:

REPREVIO was a double-blind, randomised, placebo-controlled trial conducted at 13 academic or teaching hospitals in France, Italy, the Netherlands, and Spain. Eligible participants were adult patients aged 18 years or older with Crohn's disease who underwent ileocolonic resection and had one or more risk factors for recurrence. Patients were randomly assigned within 4 weeks of surgery (1:1 ratio) to receive intravenous vedolizumab (300 mg) or placebo at weeks 0, 8, 16, and 24. Randomisation was performed centrally with a computer-generated validated variable block model and patients were stratified according to disease behaviour (fibrostenotic vs inflammatory or perforating). Ileocolonoscopy was performed at week 26 and videorecorded. Endoscopic recurrence was centrally assessed with the modified Rutgeerts score, a categorial score ranging from i0 to i4. The primary endpoint was the distribution of modified Rutgeerts scores between treatment groups at week 26, analysed by non-parametric methods. The first-ranked secondary endpoint was the proportion of patients with severe endoscopic recurrence of Crohn's disease at week 26 (modified Rutgeerts score ≥i2b). Primary and safety analyses included all patients who underwent randomisation and received at least one dose of study drug. The trial is registered with the EU Clinical Trial Register (EudraCT; 2015-000555-24).

FINDINGS:

Between May 16, 2017, and April 8, 2022, 84 patients were randomly assigned to treatment, of whom four did not receive study treatment, leaving 43 patients in the vedolizumab group and 37 in the placebo group. At week 26, the probability of a lower modified Rutgeerts score with vedolizumab versus placebo was 77·8% (95% CI 66·4 to 86·3; p<0·0001). Severe endoscopic recurrence was observed in ten (23·3%) of 43 patients in the vedolizumab group versus 23 (62·2%) of 37 patients in the placebo group (difference -38·9% [95% CI -56·0 to -17·3]; p=0·0004). Serious adverse events occurred in three (7·0%) of 43 patients who received vedolizumab (bilateral tubo-ovarian abscesses, thrombosed haemorrhoids, and pancreatic adenocarcinoma) and in two (5·4%) of 37 patients who received placebo (intestinal perforation related to Crohn's disease and severe abdominal pain).

INTERPRETATION:

Vedolizumab treatment within 4 weeks of ileocolonic resection was more likely to prevent endoscopic Crohn's disease recurrence than placebo, making this an attractive option for postoperative management in patients with risk factors for recurrence. Larger studies with longer follow-up would be desirable.

FUNDING:

Takeda Nederland.

146

News (Medical) associated with Vedolizumab

09 Dec 2024

·www.businesswire.com

Orphagen Pharmaceuticals Receives NIH Funding Award to Advance a Novel Drug for Inflammatory Bowel Disease

SAN DIEGO--( BUSINESS WIRE )-- Orphagen Pharmaceuticals, Inc. , a biotech company pioneering the screening, discovery, and development of small molecule ligands that modulate orphan or unexplored members of the nuclear receptor family, today announced an award of up to $1.7 million from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) through the Small Business Innovation Research (SBIR) program. The funding will support the preclinical development of the small molecule OR-812, a selective nuclear receptor antagonist, as a novel oral therapeutic for treatment of ulcerative colitis and Crohn’s disease, two forms of inflammatory bowel disease (IBD). “This award recognizes the innovative preclinical work that Orphagen has done to characterize retinoic acid receptor alpha (RARα) as a target for inhibiting autoimmune inflammation of the intestinal mucosa,” said Scott Thacher, Ph.D., CEO of Orphagen. “We’ll use this funding from the NIDDK to further evaluate the properties of our lead compound, OR-812, a potent and selective RARα antagonist with promising preclinical efficacy, safety, and pharmacokinetics for the treatment of IBD.” “Innovative therapeutics for autoimmune diseases of the intestinal mucosa have largely been dominated by injectable drugs. Our small molecule, OR-812, has the potential to offer IBD patients a novel oral medicine with a differentiated mechanism of action from current therapies,” added Dr. Thacher. Up to two million Americans suffer from inflammatory bowel disease (IBD), a lifelong, debilitating inflammatory condition of the gut in which modulation of the immune system is the major therapeutic strategy. However, despite development of novel therapies including monoclonal antibodies to TNFα and IL-12/IL-23, and inhibitors of T cell gut homing such as vedolizumab and ozanimod, less than half of patients experience a sustained therapeutic benefit. The research leading to this award grows out of investigations at Orphagen into unexplored members of the nuclear receptor family, which has been the source of major drugs in cancer, metabolic disease, and inflammation. One of these unexplored targets, RARα, has a central role in the intestinal immune response and regulates the induction of homing markers that drive activated T cells to migrate to the intestinal mucosa. In vivo pharmacological studies at Orphagen have shown that RARα antagonists will, with very high potency, block the induction of the gut homing integrin α4β7, the target for vedolizumab, a major inflammatory bowel disease drug. Induction of a second important gut homing receptor, CCR9, is also blocked by OR-812 during T cell activation. Potential for efficacy in this drug class was supported by studies carried out in the laboratory of Professor Casey Weaver, the Leonard H. Robinson Endowed Chair in Pathology at the University of Alabama, Birmingham, a noted pioneer in mucosal immunology. His group showed that an RARα antagonist will inhibit α4β7 expression and cause a significant reduction in accumulation of inflammatory T cells in the lamina propria of the colon of Citrobacter rodentium -infected mice, a model of gut mucosal inflammation resembling IBD. Separately, OR-812 markedly suppressed gut mucosal inflammation and erosion in a T cell transfer model of colitis in mouse, which is known to respond to most major classes of drug for IBD. Preliminary safety studies carried out at Orphagen are consistent with a robust safety margin for OR-812. Dr. Weaver commented, “Globally, there is a pressing need for new therapies as the incidence of IBD continues to increase. Selectively blocking the action of retinoic acid through RARα is clearly one promising approach.” About Crohn’s Disease and Ulcerative Colitis Inflammatory bowel disease (IBD) is an umbrella term used to describe disorders, including Crohn’s disease (CD) and ulcerative colitis (UC), that involve chronic inflammation of the gastrointestinal tract. UC is an idiopathic, chronic disorder of the large intestine mucosa, characterized by a continuous stretch of inflammation in the innermost lining of the colon wall. Half of UC patients suffer debilitating disease flares 4-5 times a year, significantly affecting their quality of life. Patients may recover after a single attack, while others require frequent hospitalizations and surgery. CD differs from UC in that it can affect any part of the intestinal tract, and it occurs in all layers of the intestinal wall within localized regions of inflammation scattered throughout the GI tract. About Orphagen Pharmaceuticals Orphagen unlocks the power of orphan nuclear receptors. Our scientists have discovered small molecule ligands to these largely unexplored drug targets. Starting with an agnostic approach to therapeutic area, we explore proprietary lead molecules with potential in autoimmune disease and oncology. Orphagen successfully partnered its first program for ROR-gamma antagonists in autoimmune disease with a mid-size pharmaceutical company ahead of all competitors in the field. Funding from our partnerships and other non-dilutive sources, including federal grants, has allowed Orphagen to advance its proprietary first-in-class drug discovery programs, including OR-812 for inflammatory bowel disease. For more info, visit www.orphagen.com .

22 Nov 2024

·www.prnewswire.com

Johnson & Johnson seeks U.S. FDA approval for subcutaneous induction regimen of TREMFYA® (guselkumab) in ulcerative colitis, a first for an IL-23 inhibitor

Following recent U.S. FDA approval of TREMFYA® for adults with moderately to severely active ulcerative colitis (UC), this submission underscores its potential to be the only IL-23 inhibitor that offers choice of subcutaneous or intravenous induction in UC Submission is supported by the Phase 3 ASTRO study, which achieved the primary endpoint of clinical remission at Week 12 and met all secondary endpoints in adults with moderately to severely active UC SPRING HOUSE, Pa., Nov. 22, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active UC. The filing is supported by data from the Phase 3 ASTRO study of TREMFYA® SC induction therapy in adults with UC and builds upon the recent U.S. approval of TREMFYA® in this indication. The Phase 3 ASTRO study met its primary endpoint, achieving a statistically significant and clinically meaningful results for clinical remission at Week 12 with a 400 mg SC induction dose of TREMFYA® administered at Weeks 0, 4, and 8. All secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI), were also met. Safety data from ASTRO were consistent with the safety findings from the QUASAR program. Results from the ASTRO study are planned for presentation at upcoming medical meetings.1 "With the ASTRO study in UC and the GRAVITI study in Crohn's disease (CD), we are focused on delivering versatility and options for administration of treatment for people with inflammatory bowel disease (IBD). TREMFYA is the first IL-23 inhibitor to potentially offer a fully SC induction and maintenance regimen, which if approved, can provide choice and simplicity for patients and providers," stated Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. "The ASTRO results add to the compelling data generated from the QUASAR program in UC and build on the promise of TREMFYA in the treatment of IBD as we look to transform outcomes for patients." TREMFYA® is the first and only approved, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC.2,3,4,5,6 TREMFYA® received U.S. FDA approval in September 2024 for the treatment of adult patients with moderately to severely active UC and is currently administered via an IV induction regimen, followed by a SC maintenance regimen. The approval was supported by data from the Phase 3 QUASAR study evaluating the efficacy and safety of TREMFYA® in adults with moderately to severely active UC.7 An application seeking approval of TREMFYA® for the treatment of adults with moderately to severely active CD has been submitted in the U.S., and applications seeking approval for both CD and UC have been submitted in Europe. ABOUT THE ASTRO STUDY (NCT05528510) ASTRO is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, treat-through Phase 3 study to evaluate the efficacy and safety of TREMFYA® SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. Patients were randomized 1:1:1 to receive TREMFYA® 400 mg SC induction at Weeks 0, 4 and 8 followed by TREMFYA® 200 mg SC q4w; or TREMFYA® 400 mg SC induction at Weeks 0, 4 and 8, followed by TREMFYA® 100 mg SC q8w; or placebo. The maintenance doses in ASTRO (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 QUASAR program that established the efficacy and safety of IV induction followed by SC maintenance therapy in patients with moderate to severely active UC.8 ABOUT THE QUASAR PROGRAM (NCT04033445) QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 2b/3 program designed to evaluate the efficacy and safety of TREMFYA® in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or JAK inhibitors (tofacitinib). QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomized withdrawal maintenance study. In the induction study, patients received either TREMFYA® 200 mg or placebo by IV infusion at Weeks 0, 4, and 8. In the maintenance study, patients received a SC maintenance regimen of either TREMFYA® 200 mg q4w, TREMFYA® 100 mg q8w, or placebo.9 ABOUT THE GRAVITI STUDY (NCT05197049) GRAVITI is a randomized, double-blind, placebo-controlled, treat-through Phase 3 study to evaluate the efficacy and safety of TREMFYA® SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active Crohn's disease who experienced an inadequate response or failed to tolerate conventional therapy (i.e., corticosteroids or immunomodulators) or biologic therapy (TNF antagonists or vedolizumab). Patients received TREMFYA® 400 mg SC at Weeks 0, 4, and 8 followed by TREMFYA® 200 mg SC q4w; or TREMFYA® 400 mg SC at Weeks 0, 4, and 8 followed by TREMFYA® 100 mg SC q8w; or placebo. The maintenance doses in GRAVITI (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 GALAXI 2 and GALAXI 3 studies that evaluated the efficacy and safety of IV induction followed by SC maintenance therapy in patients with moderate to severely active Crohn's disease).10 ABOUT ULCERATIVE COLITIS Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.11 ABOUT CROHN'S DISEASE Crohn's disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans.12 Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors. Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever.13 ABOUT TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cell that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known. TREMFYA® is a prescription medicine approved in the U.S. to treat: adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). adults with active psoriatic arthritis. adults with moderately to severely active ulcerative colitis.2 TREMFYA® is approved Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: . IMPORTANT SAFETY INFORMATION What is the most important information I should know about TREMFYA® (guselkumab)? TREMFYA® is a prescription medicine that may cause serious side effects, including: Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: Do not take TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®. Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA®?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby. Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting , by calling 1-877-311-8972, or emailing [email protected]. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy. are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of TREMFYA®? TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?" The most common side effects of TREMFYA® include respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis. These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. Use TREMFYA® exactly as your healthcare provider tells you to use it. Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. Dosage Forms and Strengths: TREMFYA® is available in a 100 mg/mL prefilled syringe and One-Press patient-controlled injector for subcutaneous injection, a 200 mg/2 mL prefilled syringe and prefilled pen (TREMFYA® PEN) for subcutaneous injection, and a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion. ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JNJInnovMed. Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen-Cilag International NV are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. 1 Data on file. 2 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504. 3 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217 4 TREMFYA® Prescribing Information. Available at: Accessed October 2024. 5 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc. 6 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company. 7 TREMFYA® Prescribing Information. Available at: Accessed October 2024. 8 National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (ASTRO). Identifier: NCT05528510. . Accessed October 2024. 9 National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR). Identifier: NCT04033445. . Accessed October 2024. 10 National Institutes of Health: Clinicaltrials.gov. A study of guselkumab subcutaneous therapy in participants with moderately to severely active Crohn's disease (GRAVITI). Identifier: NCT05197049. Available at: . Accessed October 2024. 11 Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: . Accessed April 2024. 12 Crohn's & Colitis Foundation. Overview of Crohn's disease. Available at: . Accessed October 2024. 13 Crohn's & Colitis Foundation. Signs and symptoms of Crohn's disease. Available at . Accessed October 2024. SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug Approval

19 Nov 2024

·medcitynews.com

Managing the Specialty Drug Cost Challenge: Is Your Pharmacy Benefits Strategy Ready for 2025? - MedCity News

Medicine stands at a remarkable crossroads. The explosive growth in specialty drug development marks a new golden age of therapeutic innovation. In 1990 there were just 10 specialty drugs on the market. By the middle of 2024, the FDA had already approved 23 new drug therapies, with specialty medications now representing 75% of all drugs in development. These breakthroughs offer fresh hope for patients battling rare cancers, autoimmune conditions and other life-threatening diseases while transforming life for millions living with chronic conditions like Crohn’s Disease and rheumatoid arthritis. Yet this medical renaissance comes with staggering costs. At a time when healthcare expenses are projected to surge 8% to historic highs, specialty drug prices are pushing many employers to their financial limits. The average annual cost per specialty drug now exceeds $5,000, while immunosuppressants like Humira® (Adalimumab) — one of the world’s best-selling drugs — command on average $77,000 per patient annually. Many cutting-edge therapies now carry price tags in the hundreds of thousands, with the most costly one-time curative treatments topping $1 million. Alongside these clinically validated specialty drugs — all designed to address serious, often life-threatening medical conditions — are a new set of high-priced drugs that blur the lines between medical and cosmetic treatment. Glucagon-like peptide-1 agonists (GLP-1s), originally developed for diabetes management and cardiovascular health, have rapidly become go-to treatments for weight loss and obesity, driven by celebrity endorsements and aggressive direct-to-consumer marketing. With an estimated 2% to 12% of the U.S. population already having tried GLP-1s, employers face a daunting challenge. Considering it costs $16,000 for a year’s supply of market-leading Wegovy®, it’s clear this trend threatens to overwhelm already-strained healthcare budgets. Consumer / Employer Health Executives on Digital Transformation in Healthcare Hear executives from Quantum Health, Surescripts, EY, Clinical Architecture and Personify Health share their views on digital transformation in healthcare. By MedCity News An urgent need for strategic action Employers across the spectrum are scrambling to develop benefits strategies that balance evolving member healthcare needs against increasingly unsustainable costs. Specifically, nearly two-thirds of consultants are seeing a rise in demand for guidance on specialty drug cost management, as revealed by the 2024 Benefits Consultants’ Sentiment Index (The Index), a survey conducted by MedCity News and Quantum Health. The rapidly changing GLP-1 landscape only compounds this challenge. According to The Business Group on Health’s 2024 report, 67% of large employers now cover these medications, with more planning to add coverage within the year. Facing these pressures heading into 2025, what concrete strategies should employers pursue to control rising costs while ensuring the best member experience and clinical outcomes? Exclusive Heard at HLTH 2024: Insights from Innovative Healthcare Executives Executives from Imagine360, Verily, BrightInsight, Lantern, and Rhapsody shared their approaches to reducing healthcare costs and facilitating digital transformation. By MedCity News Independent utilization management: Bending the specialty drug trend The cornerstone of any effective pharmacy benefits strategy lies in proactive utilization management. The right navigation platform with the right capabilities can go a long way to mitigating costs. You need to combine a robust navigation platform with independent care coordinators who serve as central connectors between employers, PBMs, prescribing providers and members. A platform with unique access to real-time data and insights makes it possible to intervene early for prior authorization reviews to proactively anticipate specialty drug requests and potentially change the trajectory of care before a claim is filed. Through rigorous application of authorization protocols and armed with the right data, independent care coordinators can review medication requests against a strict set of criteria to ensure that dosage and frequency align with clinical guidelines; treatments meet established coverage criteria; alternative therapies have been thoroughly explored; and member-specific factors, including side effects and drug interactions, are carefully weighed. The resulting impact of this proactive utilization management strategy can be significant. A 2023 Quantum Health study of 1.8 million of its plan members across 200 employers demonstrated the potential for such a strategy. While 98% of reviewed specialty drug requests analyzed received approval, by mitigating wasteful, clinically inappropriate spending the average employer realized $1.37 per member per month (PMPM) in savings — for a total annualized savings of $35 million across employers. Biosimilars — lower-priced medications that are highly similar and as safe and effective as reference biologic drugs — offer another powerful cost-control lever. These FDA-approved alternatives cost on average 50% less than reference drugs, potentially saving $180 billion industry-wide over the next five years. Independent healthcare navigation can leverage the unique ability to engage with both members and providers to accelerate adoption of these innovative alternatives, leading to significant cost savings. Site of care: Shifting treatment to the right place for the best member experience After ensuring appropriate specialty drug access through utilization management, determining the most optimal administration settings becomes crucial. In another analysis, 220 drugs were identified — representing 63% of clients’ specialty drug costs — where hospital-based administration isn’t clinically necessary or cost-effective. In 91% of eligible cases, transitioning member treatments to lower-cost settings like medical offices or homes was shown to reduce treatment costs by 48%. On top of cost savings, employers cannot undervalue the improved health experience and productivity impacts that result from shifting members’ sites of care. Consider a member we’ll call Edward who works as a clinical director for a large medical device company. At the age of 34, he began to experience worsening digestive issues, including abdominal pain, diarrhea, fever, fatigue and joint pains, and was diagnosed with Crohn’s disease — a life-altering diagnosis for a busy professional. He now needed treatment with a complex and costly specialty medication to manage his symptoms of abdominal pain and fatigue while staying focused and productive in his role and career. His gastroenterologist started Edward on Entyvio® (vedolizumab), which required him to travel every 8 weeks to an outpatient hospital setting. He responded well to the treatment and saw a dramatic improvement in his symptoms. Leveraging data from a healthcare navigation platform, independent care coordinators were able to identify an opportunity to move his treatments to his home. This shift not only reduced costs for both him and his employer but made it possible for Edward to live with and manage his condition without compromising his busy work schedule. The GLP-1 access challenge: Navigation and member engagement are critical The unprecedented demand for GLP-1s presents benefits leaders with another set of complex utilization management challenges. While these drugs show remarkable promise — offering transformative benefits for diabetes, cardiovascular disease kidney disease and severe obesity, with potential applications in addiction treatment — their widespread adoption for general weight loss requires careful oversight. Recent research underscores the importance of thoughtful management: A recent JAMA study identified rare but serious risks, while another study revealed that early discontinuation can negate clinical benefits entirely. As GLP-1 demand grows, these and other complex considerations and variables can only be tracked and managed through an expert navigation partner and platform capable of wrap-around member and provider engagement. Preparing for a promising, but costly, new era of specialty drug development Heading into 2025, the specialty drug pipeline continues to expand exponentially, driven particularly by emerging cell and gene therapies (CGTs). By 2027, projections suggest 2% to 3% of members will use specialty medications, accounting for 56% of employers’ total drug spend. GLP-1 development maintains similar momentum, with over 120 new formulations in development as of April 2024. Meanwhile the market for quick and easy weight loss solutions shows no sign of abating. Success in the year ahead, and beyond, will require benefits leaders to rethink and future-proof their benefits programs and seek out navigation partners that have the capabilities required to manage both sides of their specialty pharmacy costs. By implementing robust utilization management, optimizing treatment settings, and partnering with independent navigation experts with wrap-around care management, employers can ensure members have access to revolutionary treatments while keeping costs sustainable.

100 Deals associated with Vedolizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D08083	Vedolizumab	L04AA33	DB09033

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Ileal Diseases	KR	Takeda Pharmaceuticals Korea Co. Ltd.	19 Jun 2015
Crohn's disease, active moderate	EU	Takeda Pharma A/S	22 May 2014
Crohn's disease, active moderate	IS	Takeda Pharma A/S	22 May 2014
Crohn's disease, active moderate	LI	Takeda Pharma A/S	22 May 2014
Crohn's disease, active moderate	NO	Takeda Pharma A/S	22 May 2014
Crohn's disease, active severe	EU	Takeda Pharma A/S	22 May 2014
Crohn's disease, active severe	IS	Takeda Pharma A/S	22 May 2014
Crohn's disease, active severe	LI	Takeda Pharma A/S	22 May 2014
Crohn's disease, active severe	NO	Takeda Pharma A/S	22 May 2014
Pouchitis	EU	Takeda Pharma A/S	22 May 2014
Pouchitis	IS	Takeda Pharma A/S	22 May 2014
Pouchitis	LI	Takeda Pharma A/S	22 May 2014
Pouchitis	NO	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active moderate	EU	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active moderate	IS	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active moderate	LI	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active moderate	NO	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active severe	EU	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active severe	IS	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active severe	LI	Takeda Pharma A/S	22 May 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Graft Versus Host Disease	Phase 3	US	Millennium Pharmaceuticals, Inc.	06 Feb 2019
Acute Graft Versus Host Disease	Phase 3	JP	Millennium Pharmaceuticals, Inc.	06 Feb 2019
Acute Graft Versus Host Disease	Phase 3	AR	Millennium Pharmaceuticals, Inc.	06 Feb 2019
Acute Graft Versus Host Disease	Phase 3	AU	Millennium Pharmaceuticals, Inc.	06 Feb 2019
Acute Graft Versus Host Disease	Phase 3	AT	Millennium Pharmaceuticals, Inc.	06 Feb 2019
Acute Graft Versus Host Disease	Phase 3	BE	Millennium Pharmaceuticals, Inc.	06 Feb 2019
Acute Graft Versus Host Disease	Phase 3	BR	Millennium Pharmaceuticals, Inc.	06 Feb 2019
Acute Graft Versus Host Disease	Phase 3	CA	Millennium Pharmaceuticals, Inc.	06 Feb 2019
Acute Graft Versus Host Disease	Phase 3	FR	Millennium Pharmaceuticals, Inc.	06 Feb 2019
Acute Graft Versus Host Disease	Phase 3	DE	Millennium Pharmaceuticals, Inc.	06 Feb 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW	Not Applicable	Colitis, Ulcerative	-	Vedolizumab IV infusion every 8 weeks (Q8W)	bmlyqhcpum(lacylbbttv) = crholacqtg fagmcssyyh (pvfyzifozt ) View more	-	13 Oct 2024
				Vedolizumab IV infusion every 4 weeks (Q4W)	bmlyqhcpum(lacylbbttv) = ylnkbwstkx fagmcssyyh (pvfyzifozt ) View more
UEGW2024	Not Applicable	Colitis, Ulcerative	-	Vedolizumab	mqztfmhplf(hcdugpsjkh) = In the first study, safety outcomes were followed from treatment initiation up to five half-lives after treatment discontinuation; 6.8% treated with Vedolizumab experienced SAEs compared with 19.2% with anti-tumour necrosis factor-alpha treatment. In the second study, the rate of SAEs was similar between patients treated with Vedolizumab (4.5%) and anti-tumour necrosis factor-alpha treatment (5.0%). In the third study that reported SAEs within the first year of treatment; the rates of SAEs were 14.3% and 10.9% among patients who received Vedolizumab and anti-tumour necrosis factor-alpha treatment, respectively. nkwmsnsddl (wgeqjrczpt )	-	13 Oct 2024
				Anti-tumour necrosis factor-alpha treatment
UEGW	Not Applicable	Colitis, Ulcerative	-	Vedolizumab	yunsrqhokg(ewtwxzfbrk) = gragokavue saacijrctc (xhlngcfrtn, 37.0–48.3)	-	13 Oct 2024
ESMO_IO2024	Not Applicable	Colitis	74	Vedolizumab	fzeqscwslb(nimeqpflcp) = ndchchjmcc otnpjfltkb (ocizavtkfk )	-	14 Sep 2024
NCT02790138 (EARNEST, Pubmed)	Phase 3	Pouchitis	-	Vedolizumab	phrwlosmez(advpqwubfz) = iomyhrrqnm ocwbzxqyid (qnkvfvsdkk ) View more	Positive	16 Jul 2024
				Placebo	phrwlosmez(advpqwubfz) = gaqsvczggh ocwbzxqyid (qnkvfvsdkk ) View more
NCT02764762 (EXPLORER, Pubmed \| Clin Gastroenterol Hepatol) Manual	Phase 4	Crohn's disease, active severe	55	Vedolizumabadalimumabmethotrexate	hssecenbbx(khdsxjpmov) = qamwzdowms wrzepbvnej (bpsgxpyehn ) View more	Positive	01 Jul 2024
NCT03657160 (Pubmed)	Phase 3	Hematopoietic stem cell transplantation	343	Vedolizumab	ksceosuani(ubqqqlszmg) = dohoozulkc rjeynwaozf (apemlytqbz, 79.2 - 90.1)	Positive	06 Jun 2024
				Placebo	ksceosuani(ubqqqlszmg) = knrtafsuxf rjeynwaozf (apemlytqbz, 63.2 - 77.2)
NCT03029143 (ENTERPRET, Pubmed) Manual	Phase 4	Colitis, Ulcerative	108	Standard Vedolizumab Dosing (300 mg every 8 weeks)	vhjafgwyam(npihbrcxet) = zciliaggyq gmsbyvxdxq (gctjetzfxz ) View more	Positive	01 May 2024
				Dose-Optimized Vedolizumab (600 mg at week 6, then 300 mg every 4 weeks; or 600 mg at week 6, then 600 mg every 4 weeks)	vhjafgwyam(npihbrcxet) = ucyncbsblq gmsbyvxdxq (gctjetzfxz ) View more
CD Trial III (FDA_CDER) Manual	Not Applicable	Crohn Disease	461	Intravenous ENTYVIO 300 mg every eight weeks	uydmbcugjz(peuijqyrya) = hafqmieydj vgyktscuzn (ndrgfjmias ) View more	Positive	18 Apr 2024
				Intravenous ENTYVIO 300 mg every four weeks	-
CD Trial II (FDA_CDER) Manual	Not Applicable	Crohn Disease	683	ENTYVIO (CD Trial I)	biyeaiuamp(cvlelzsarp) = tlylwanmvp jajmiwqtda (eamrimmvzi )	Positive	18 Apr 2024
				ENTYVIO (CD Trial II)	biyeaiuamp(cvlelzsarp) = yjabwgbwoy jajmiwqtda (eamrimmvzi )

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