This is an open-label study designed to evaluate the long-term safety and efficacy of evinacumab, a fully human ANGPTL3 antibody, in patients with homozygous familial hypercholesterolemia (HoFH), in a real-life setting in Canada.
Eligible patients for this study are male and female adult patients with HoFH. Evinacumab will be added on top of the patient's background lipid-modifying therapy (LMT), including statins, ezetimibe, PCSK9 inhibitors, lomitapide or other lipid lowering therapies. This study will be conducted using an hybrid (on-site, foldable sites) approach. Patients will enter the current study, in an open-label treatment period, following their screening. This study will continue until reimbursement of evinacumab in Canada or for a maximum of 24 months. The end of study (EoS) visit will be scheduled 4 weeks after the last dose has been injected and will be followed by a 52-week follow-up.

Start Date21 Feb 2023

Sponsor / Collaborator

Ultragenyx Pharmaceutical, Inc.

NCT04863014

/ TerminatedPhase 2

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis

The primary objective of the study is to determine the proportion of patients with elevated triglycerides (TG), without familial chylomicronemia syndrome (FCS) due to loss of function (LoF) mutations in lipoprotein lipase (LPL), and a history of hypertriglyceridemia (HTG)-associated acute pancreatitis (AP) who experience a recurrent episode of AP after treatment with evinacumab versus placebo.
The secondary objectives of the study are:
To determine the change in the standard lipid profile after therapy with evinacumab versus placebo
To determine the changes in specialty lipoprotein parameters (ApoC3, ApoB48, ApoB100, and nuclear magnetic resonance [NMR] lipid profile) after therapy with evinacumab versus placebo
To measure the number of AP episodes per patient
To assess the safety and tolerability of evinacumab
To assess the potential immunogenicity of evinacumab
To assess the concentrations of total evinacumab and total angiopoietin-like 3 (ANGPTL3)

Start Date12 Jul 2021

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

100 Clinical Results associated with Evinacumab-dgnb

100 Translational Medicine associated with Evinacumab-dgnb

100 Patents (Medical) associated with Evinacumab-dgnb

134

Literatures (Medical) associated with Evinacumab-dgnb

01 Dec 2024·Current Atherosclerosis Reports

Homozygous Familial Hypercholesterolemia Treatment: New Developments

Review

Author: Blom, Dirk J ; Raal, Frederick J ; Marais, A David

AbstractPurpose of reviewHomozygous familial hypercholesterolaemia (HoFH) is characterized by marked elevation of low-density lipoprotein cholesterol (LDLC) and premature atherosclerotic cardiovascular disease. This is a review of novel pharmacological therapies to lower LDLC in patients with HoFH.Recent findingsNovel therapies can be broadly divided by whether their efficacy is dependent or independent of residual low-density lipoprotein receptor (LDLR) function. Novel LDLR dependent therapies that reduce proprotein subtilisin kexin type 9 levels include monoclonal antibodies (alirocumab and evolocumab) and a small inhibitory RNA (inclisiran). LDLC reductions are highly variable and depend on residual LDLR function. Microsomal triglyceride inhibitors (lomitapide) and therapies that reduce angiopoietin like factor 3 (evinacumab and zodasiran) both reduce LDLC by approximately 50%, irrespective of residual LDLR function. Summary Most patients with HoFH require multiple therapies to achieve LDLC targets. Better LDLC control with LDLR independent therapies is likely to improve the outlook for patients with HoFH while at the same time reducing the need for other therapies such as apheresis or hepatic transplantation.

11 Nov 2024·European Journal of Preventive Cardiology

Current treatments for the management of homozygous familial hypercholesterolaemia: a systematic review and commentary

Review

Author: Cheng, Henry K ; Gu, Jing ; Xu, Yingxin ; Raal, Frederick J ; Gupta, Rupal N

AbstractAimsHomozygous familial hypercholesterolaemia (HoFH) is a rare disorder characterized by markedly elevated circulating low-density lipoprotein cholesterol (LDL-C) from birth. This review aimed to critically evaluate treatments for HoFH with respect to their efficacy, safety, accessibility, overall context and position within the treatment pathway.Methods and resultsA mixed-methods review was undertaken to systematically identify and characterize primary interventional studies on HoFH, with a focus on LDL-C reduction as the primary outcome. Interventions assessed were ezetimibe, proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i), lomitapide, evinacumab, with or without LDL apheresis. Twenty-six seminal studies reporting unique patient data were identified. Four studies were randomized controlled trials (RCTs) with the remainder being single-arm trials or observational registries. Data extracted were heterogeneous and not suitable for meta-analyses. Two RCTs, assessed at being low risk of bias, demonstrated PCSK9i were safe and moderately effective. A randomized controlled trial (RCT) demonstrated evinacumab was safe and effective in all HoFH subgroups. Lomitapide was reported to be efficacious in a single-arm trial, but issues with adverse events, tolerability, and adherence were identified. An RCT on ezetimibe showed it was moderately effective when combined with a statin. LDL apheresis was reported as effective, but its evidence base was at very high risk of bias. All interventions lowered LDL-C, but the magnitude of this, and certainty in the supporting evidence, varied.ConclusionIn practice, multiple treatments are required to treat HoFH. The sequencing of these should be made on an individualized basis, with consideration made to the benefits of each intervention.

21 Oct 2024·European Heart Journal

Correction to: Evinacumab in homozygous familial hypercholesterolaemia: long-term safety and efficacy

120

News (Medical) associated with Evinacumab-dgnb

13 Jan 2025

·pipelinereview.com

Adjuvant Libtayo® (cemiplimab) Significantly Improves Disease-Free Survival (DFS) After Surgery in High-Risk Cutaneous Squamous Cell Carcinoma (CSCC) in Phase 3 Trial

Primary endpoint of DFS met at first prespecified interim analysis, showing a 68% reduction in the risk of disease recurrence or death in patients with high-risk CSCC after surgery compared to placebo Libtayo is the first and only immunotherapy to show a statistically significant and clinically meaningful benefit in high-risk CSCC in the adjuvant setting; a recent Phase 3 trial with Keytruda ® failed in the same setting 1 Libtayo is standard of care for certain patients with advanced CSCC TARRYTOWN, NY, USA I January 13, 2025 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive results from the Phase 3 C-POST trial, which demonstrated that adjuvant treatment with PD-1 inhibitor Libtayo ® (cemiplimab) led to a statistically significant and clinically meaningful improvement in the primary endpoint of disease-free survival (DFS) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery. “While surgery is curative for most people living with cutaneous squamous cell carcinoma, many are burdened with a higher risk of recurrence that can lead to death or disfiguration,” said Danny Rischin, M.D., M.B.B.S., F.R.A.C.P., Research Lead, Head and Neck Cancer and Cutaneous SCC, Department of Medical Oncology at the Peter MacCallum Cancer Centre in Melbourne, Australia, and lead investigator of the trial. “At the first prespecified interim analysis, Libtayo achieved a remarkably high bar in improving disease-free survival in high-risk cutaneous squamous cell carcinoma. With no currently approved options in the adjuvant setting, these landmark results demonstrate Libtayo could represent a major advance in delaying recurrence in these vulnerable patients.” C-POST enrolled 415 patients with high-risk CSCC who were randomized to receive either Libtayo or placebo for up to 48 weeks. The primary endpoint was DFS, defined as time from randomization to the first documented disease recurrence or death due to any cause. At the first prespecified interim analysis for DFS with a median duration of follow-up of 24 months (range: 2-64 months), Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death, compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001). Safety was assessed in 205 patients in the Libtayo arm and 204 patients in the placebo arm. Adverse events (AEs) of any grade occurred in 91% and 89% of patients in the Libtayo arm and the placebo arm, respectively. Grade ≥3 AEs occurred in 24% and 14% of patients in the Libtayo arm and the placebo arm, respectively. Treatment discontinuations due to adverse reactions occurred in 10% and 1.5% of patients in the Libtayo arm and the placebo arm, respectively. Two patients experienced an AE leading to death in each arm. Following these interim results, C-POST will continue for additional follow-up, including an analysis of the key secondary endpoint of overall survival. Detailed results will be presented at an upcoming medical meeting and will be shared with regulatory authorities with a plan for U.S. Food and Drug Administration (FDA) submission in the first half of 2025. “Regeneron has long been a pioneer in non-melanoma skin cancer research. Libtayo was the first PD-1 inhibitor approved for certain patients with advanced cutaneous squamous cell carcinoma and has become a standard of care in this setting,” said Israel Lowy, M.D., Ph.D., Clinical Development Unit Head, Oncology, at Regeneron. “With these results, Libtayo now has the potential to also transform the treatment of high-risk resectable cutaneous squamous cell carcinoma with adjuvant treatment. This trial is a testament to our unrelenting commitment to investigating areas where patient need remains high and to pursuing clinical research across diverse stages of skin cancer.” The potential use of Libtayo described above is investigational, and its safety and efficacy has not been evaluated by any regulatory authority for this indication. About the Phase 3 Trial C-POST is an ongoing randomized, placebo-controlled, double-blind, multicenter, global Phase 3 trial investigating Libtayo versus placebo as adjuvant treatment for patients with features associated with a high-risk of CSCC recurrence and who have completed surgery and post-operative radiation therapy. Trial participants are at high risk of recurrence due to nodal features (extracapsular extension or ≥3 involved lymph nodes) and/or non-nodal features (in-transit metastases, T4 lesion, perineural invasion, or locally recurrent tumor with ≥1 additional poor prognostic features). For the first 12 weeks, Libtayo 350 mg or placebo is administered intravenously every three weeks, followed by Libtayo 700 mg or placebo administered intravenously every six weeks for 36 weeks. The primary endpoint is DFS, and the secondary endpoints include freedom from locoregional recurrence, freedom from distant recurrence, overall survival, cumulative incidence of second primary CSCC tumors, and safety. The Trans-Tasman Radiation Oncology Group (TROG), with Dr. Rischin as lead investigator, collaborated with Regeneron on protocol development. Trial sites included 24 TROG sites in Australia. About Regeneron in Cancer We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time. Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we’re pursuing potential therapies across more than 30 types of solid tumors and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron’s pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations. To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care. About Libtayo Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron’s proprietary VelocImmune ® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. Libtayo has been approved by regulatory authorities in more than 30 countries in one or more indications, including for certain adult patients with advanced basal cell carcinoma (BCC), advanced CSCC, advanced non-small cell lung cancer (NSCLC) and advanced cervical cancer. In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. FDA. Outside of the U.S., the generic name of Libtayo in its approved indications is cemiplimab. The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority. U.S. FDA-approved Indications Libtayo is a prescription medicine used to treat: It is not known if Libtayo is safe and effective in children. Please see full Prescribing Information , including Medication Guide . About Regeneron’s VelocImmune Technology Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite ® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes Dupixent ® (dupilumab), Libtayo, Praluent ® (alirocumab), Kevzara ® (sarilumab), Evkeeza ® (evinacumab-dgnb), Inmazeb ® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz ® (pozelimab-bbfg). In addition, REGEN-COV ® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite ® , which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center ® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn , Instagram , Facebook or X . 1 Data not yet published. https://www-merck-com.libproxy1.nus.edu.sg/news/merck-provides-update-on-phase-3-keynote-867-and-keynote-630-trials/ . All trademarks used are the property of their respective owners. The studies had differences in trial design specifics and no head-to-head comparisons have been conducted. SOURCE: Regeneron Pharmaceuticals

Clinical ResultPhase 3Drug Approval

07 Jan 2025

·www.globenewswire.com

European Commission (EC) Extends the Approval of Evkeeza® (evinacumab) to Children as Young as 6-months Old with Homozygous Familial Hypercholesterolemia (HoFH)

Jan. 06, 2025 -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialisation of novel therapies for rare and ultrarare genetic diseases, today announced that the European Commission (EC) has extended the approval of Evkeeza® (evinacumab) as an adjunct to diet and other lipid-lowering therapies to treat children aged 6-months and older with homozygous familial hypercholesterolemia (HoFH). Evkeeza, an angiopoietin-like 3 (ANGPTL3) inhibitor, is the first medicine indicated for children in the European Union (EU) as young as 6-months old to treat HoFH, a disease associated with dangerously high levels of low-density lipoprotein cholesterol (LDL-C). "For very young children suffering from homozygous HoFH, leading to dangerously high LDL-C levels and early cardiovascular disease, treatment options are limited. Many young children don't reach treatment goals, leaving them with an uncertain future,” stated Albert Wiegman, M.D., Ph.D. and Professor, Department of Paediatrics at Amsterdam University Medical Center. “Evinacumab has demonstrated significant LDL-C reductions in adults, adolescents, and children with HoFH from 5-years onwards. The current label expansion for children younger than 5-years illustrates the potential of this medicine to help them control their LDL-C levels at even earlier age in the course of their disease." This EC decision follows the positive recommendation received from the Committee for Medicinal Products for Human Use in November 2024.The efficacy of Evkeeza in paediatric patients aged 6 months to less than 5 years with HoFH has been predicted from a model-based extrapolation analysis. Results of these analyses show that paediatric patients aged 6 months to less than 5 years are predicted to experience a similar or higher magnitude of percent change in LDL-C at week 24 compared to adults, when receiving a 15 mg/kg dose every 4 weeks. In addition, supportive data for five patients between 1 and 4 years old with HoFH who received Evkeeza via compassionate use show a clinically meaningful reduction of LDL-C consistent with that observed in patients aged 5 years or older in clinical studies. Based on the currently available data, the safety profile in pediatric patients aged 6-months to 5 years old is expected to be similar to the safety profile in older pediatric patients. No new safety concerns have been identified in the compassionate use program. “The international community of parents and caregivers of children with HoFH welcomes this approval, because this is a potentially life-changing therapy for the children and their parents affected by this rare and severe disorder,” stated Magdalena Daccord, chief executive officer of FH Europe Foundation. “As we advocate for childhood screening and detection to help improve early HoFH diagnosis, it is key to be able to offer to young patients appropriate and innovative treatment solutions along with lifestyle management. That said, it will be a true success once this therapy option is available to all those who need it as soon as they need it.” Evkeeza initially received approval as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C)-lowering therapies for the treatment of adult and adolescent patients aged 12 years and older with HoFH in June 2021. The indication was later extended to include children aged 5 to 11 years old with HoFH, with EC decision for that variation received in December 2023. The treatment is now reimbursed and commercially available to prescribe for appropriate patients with HoFH in the UK, U.S., Canada, Italy, Japan, the Netherlands, Spain and Luxembourg. It is also available via early access schemes in 13 additional countries including Austria and France. "HoFH can cause severe cardiovascular events including heart attacks even in young children, making diagnosing it and reducing the high LDL-C levels it causes an urgent matter,” said Jane Cooper, senior vice president, EMEA region head at Ultragenyx. “We are proud to be able to provide children as young as 6-months old living with HoFH the first approved medicine to reduce LDL-C levels and hope that it will support a fundamental shift in the management of the disease.” HoFH is a devastating form of inherited hypercholesterolemia, affecting 1 in 300,000 people globally and approximately 1,600 people in the European Union. HoFH occurs when two copies of the familial hypercholesterolemia (FH)-causing genes are inherited, one from each parent, resulting in dangerously high levels (>400 mg/dL) of LDL-C, or bad cholesterol. Patients with HoFH are at risk for premature atherosclerotic disease and cardiac events at an early age. Evinacumab, the active substance in Evkeeza, attaches to a protein in the body called ANGPTL3 and blocks its effects. ANGPTL3 is involved in controlling cholesterol levels and blocking its effect reduces the level of cholesterol in the blood. Evkeeza is delivered via an infusion every month (4 weeks). Evkeeza is approved by the European Commission (EC) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of adult and paediatric patients aged 6-months and older with homozygous familial hypercholesterolemia (HoFH). Regeneron Pharmaceuticals, Inc. discovered and developed Evkeeza, and commercializes the product in HoFH in the U.S. under the generic name evinacumab-dgnb, with dgnb as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the FDA. Ultragenyx is responsible for development and commercialization efforts for Evkeeza in countries outside of the U.S. Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment of serious rare and ultrarare genetic diseases. The company has built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are typically no approved therapies treating the underlying disease. The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency. The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalLicense out/in

06 Jan 2025

·www.pharmaceutical-technology.com

Ultragenyx’s Evkeeza secures EU approval for young children with rare cholesterol disorder

Evkeeza is the first medicine indicated for children in the EU as young as six months old to treat HoFH. Credit: FatCamera via Shutterstock. The European Commission (EC) has extended the approval of Ultragenyx Pharmaceutical’s Evkeeza (evinacumab) to include children aged six months to less than five years with homozygous familial hypercholesterolemia (HoFH). The decision, which follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in November 2024, makes Evkeeza the first approved treatment for this patient group in the EU. Evkeeza was first approved in the EU in June 2021 for adults and adolescents aged 12 years and older with HoFH. The indication was expanded in December 2023 to include children aged five to 11 years. HoFH is a rare and life-threatening genetic disorder characterised by extremely high levels of low-density lipoprotein cholesterol (LDL-C) from birth. Without effective treatment, patients are at significant risk of early cardiovascular complications and premature death. Standard care for HoFH involves a combination of diet, lipid-lowering therapies, and in some cases LDL apheresis—a procedure that removes cholesterol from the bloodstream. Evkeeza is approved for use in conjunction with diet and other lipid-lowering therapies. The EC’s decision was supported by model-based extrapolation of efficacy data from adult patients. Analyses predict that children aged six months to less than five years receiving a 15mg/kg dose of Evkeeza every four weeks would achieve similar or greater LDL-C reductions at 24 weeks compared to adults. Additionally, compassionate use data from five children aged one to four years showed clinically meaningful reductions in LDL-C, consistent with results observed in older paediatric patients. The safety profile for this age group is expected to align with that of older children, with no new safety concerns reported. In the announcement accompanying the approval, Jane Cooper, senior vice president and EMEA region head at Ultragenyx, said: “We are proud to be able to provide children as young as six months old living with HoFH the first approved medicine to reduce LDL-C levels and hope that it will support a fundamental shift in the management of the disease.” Evkeeza was discovered and developed by Regeneron Pharmaceuticals, which markets the therapy in the US, whereas Ultragenyx is responsible for its development and commercialisation outside the US. Evkeeza generated $3.6m for Ultragenyx in 2023, as per the company’s financials. According to Regeneron’s 2023 financials, the therapy generated $77.3m in the US in the same year. GlobalData forecasts that Evkeeza will make up to $245m in sales by 2030. GlobalData is the parent company of Pharmaceutical Technology. Evkeeza is a monoclonal antibody (mAb) that is delivered by infusion every month. Regeneron also investigated the therapy in pancreatitis, but a Phase II trial (NCT04863014) was terminated in March 2023 due to a “sponsor decision”.

Drug ApprovalPhase 2

100 Deals associated with Evinacumab-dgnb

External Link

KEGG	Wiki	ATC	Drug Bank
D11753	Evinacumab-dgnb	C10	DB15354

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Indication	Country/Location	Organization	Date
Homozygous familial hypercholesterolemia	US	Regeneron Pharmaceuticals, Inc.	11 Feb 2021

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Indication	Highest Phase	Country/Location	Organization	Date
Homozygous familial hypercholesterolemia	Phase 3	IT	Regeneron Pharmaceuticals, Inc.	18 Jan 2018
Homozygous familial hypercholesterolemia	Phase 3	AU	Regeneron Pharmaceuticals, Inc.	18 Jan 2018
Homozygous familial hypercholesterolemia	Phase 3	GR	Regeneron Pharmaceuticals, Inc.	18 Jan 2018
Homozygous familial hypercholesterolemia	Phase 3	UA	Regeneron Pharmaceuticals, Inc.	18 Jan 2018
Homozygous familial hypercholesterolemia	Phase 3	AT	Regeneron Pharmaceuticals, Inc.	18 Jan 2018
Homozygous familial hypercholesterolemia	Phase 3	NL	Regeneron Pharmaceuticals, Inc.	18 Jan 2018
Homozygous familial hypercholesterolemia	Phase 3	FR	Regeneron Pharmaceuticals, Inc.	18 Jan 2018
Homozygous familial hypercholesterolemia	Phase 3	CA	Regeneron Pharmaceuticals, Inc.	18 Jan 2018
Homozygous familial hypercholesterolemia	Phase 3	JP	Regeneron Pharmaceuticals, Inc.	18 Jan 2018
Homozygous familial hypercholesterolemia	Phase 3	ZA	Regeneron Pharmaceuticals, Inc.	18 Jan 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04863014 (CTgov)	Phase 2	Hypertriglyceridemia \| Pancreatitis	21	Placebo (Placebo)	fbloawsqar(kfsrnjmqdr) = frgptpnzmb klumqumbsw (xhbyzrqcyj, cijfizgovg - bvucwhzmyg) View more	-	22 May 2024
				evinacumab (Evinacumab)	fbloawsqar(kfsrnjmqdr) = mdnusahsya klumqumbsw (xhbyzrqcyj, kflzpgpqmk - zjfznaflxv) View more
NCT04233918 (Pubmed) Manual	Phase 3	Homozygous familial hypercholesterolemia	14	evinacumab 15 mg/kg	(sqrnfmjlzz) = tmlhvcaajd mvfvftgahq (ppfazohalh ) View more	Positive	30 Jan 2024
NCT04233918 (phase 3, part B, CTgov)	Phase 3	Homozygous familial hypercholesterolemia	20	Evinacumab (Part A: Evinacumab 15mg/Kg IV)	yncnzlzwoy(vpygeefuiu) = dqxwnvagad tttituscpf (mvdwittxcd, fddsooncgz - bkmffwfotu) View more	-	07 Jun 2023
				Evinacumab (Part B: Evinacumab 15mg/Kg IV Q4W)	rwxgirhivk(makxzuvogt) = wamihveokf abdqzgimvn (rmhwinsguc, tgmkirulbc - lvsbdfjnfr) View more
NCT04233918 (Corporate Publications) Manual	Phase 3	Hypercholesterolemia	14	EVINACUMAB	(hrzaxvjyrn) = nbucrlborl zwpyzeqltp (hrecrzwmlp ) View more	Positive	21 May 2022
NCT03399786 (CTgov)	Phase 3	Homozygous familial hypercholesterolemia	65	Placebo (Placebo IV Q4W)	gbeucfbrkz(zishlddnbm) = uxxnfjquxe teuejcdtwu (eysmrtwpru, jkalzebldv - gxnqnprpze) View more	-	18 May 2021
				Evinacumab (Evinacumab 15 mg/kg IV Q4W)	gbeucfbrkz(zishlddnbm) = lhwucifoer teuejcdtwu (eysmrtwpru, ggcdfgmbmi - bjkxdjhjca) View more
NCT03399786 (Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 3	Homozygous familial hypercholesterolemia	65	Evinacumab	(bfpcjzofsm) = uvlvbxphzm lklxzelsdv (uqislhpnlc )	Positive	20 Aug 2020
				Placebo	(bfpcjzofsm) = fzmetapwmf lklxzelsdv (uqislhpnlc )
NCT02265952 (CTgov)	Phase 2	Homozygous familial hypercholesterolemia	9	REGN1500 (REGN1500 250 mg SC/15 mg/kg IV/450 mg SC)	ozinvykyqm(xcwtvmuefc) = ckerqxiyxo krmuuqfmbf (xhmglyhhff, wgworumhmg - pqekqbmglw) View more	-	09 Dec 2019
				REGN1500 (REGN1500 300 mg SC/20 mg/kg IV)	celcqaeihy(gjunfjizrp) = hsgipsxnek uokkwiolfn (mmrinkkgzo, clefokfyio - aewuchulao) View more
NCT02265952 (Pubmed) Manual	Phase 2	Homozygous familial hypercholesterolemia	9	evinacumab	(tadponjatq) = vhpgisipow yzaigvimfd (ozeidfbdkh, 18)	Positive	01 Nov 2019
NCT02265952 (ESC2017)	Phase 2	Homozygous familial hypercholesterolemia LDL-receptor mutations \| ANGPTL3	9	Evinacumab	(dragxoramd) = ykolxxtgdd bzqaobolsj (eznrisuypo ) View more	-	29 Aug 2017

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