Enthesitis-Related Arthritis

Pictured: Novartis logo on building in California/iStock, JHVEPhoto The FDA on Tuesday expanded the label of Novartis’ IL-17A inhibitor Cosentyx (secukinumab) to cover moderate to severe hidradenitis suppurativa in adults, a painful long-term skin condition. Cosentyx is the first and only FDA-approved fully human biologic that directly targets IL-17A cytokine and is the first new biologic treatment option for hidradenitis suppurativa (HS) in almost a decade, according to Novartis’ announcement. With Tuesday’s approval, Cosentyx will now come into competition with AbbVie’s blockbuster antibody Humira (adalimumab), which became the U.S.’s first FDA-approved HS therapy in September 2015. Unlike Cosentyx, Humira targets TNF-alpha, another molecule involved in the pro-inflammatory cascade. This mechanism of action has also won Humira other indications, including rheumatoid arthritis, Crohn’s disease and plaque psoriasis. Cosentyx, a human IgG1 monoclonal antibody, targets IL-17A to block its interaction with the counterpart receptor, thereby suppressing the pro-inflammatory signaling cascade. It was first approved in 2015 and is also indicated for the treatment of plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, enthesitis-related arthritis and non-radiographic axial spondyloarthritis. “HS is one of the most devastating and exhausting skin diseases,” Donna Atherton, founder and chief mission officer at the International Association of Hidradenitis Suppurativa Network, said in a statement. The condition is chronic and systemic and is characterized by boil-like lumps that typically burst into open wounds, which often result in irreversible scarring. HS flare-ups can cause debilitating pain that disrupts work and social participation, as well as pose a heavy emotional and mental toll on patients. Central to the disease’s pathology is the IL-17 pathway, which is dysregulated and overactivated in HS and gives rise to its inflammation-driven symptoms. “The approval of a new treatment option brings fresh hope to me and the HS community that we may find relief from the burden of the disease,” Atherton said. The FDA based its approval on data from the SUNSHINE and SUNRISE studies, the largest Phase III program in HS to date, according to Novartis’ news release. Together, these studies showed that Cosentyx-treated patients achieved significantly higher rates of clinical response compared to placebo. The IL-17A inhibitor demonstrated efficacy as early as week 2, progressively improved through week 16 and persisted until week 52. SUNRISE and SUNSHINE also found a safety pro Cosentyx that was consistent with what had been established in prior studies. Also eyeing a portion of the HS market is UCB, which is advancing the dual IL-17A and IL-17F inhibitor bimekizumab. In March 2023, the company reported clinically meaningful, deep and persistent treatment response in the Phase III BE HEARD I and BE HEARD II studies. At the time, UCB was gearing up for global regulatory submissions for bimekizumab in this indication starting in the third quarter of 2023. Bimekizumab won the FDA’s approval in October 2023 for plaque psoriasis, for which it is sold under the brand name Bimzelx. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

FDA approval based on robust Phase III data in which Cosentyx® (secukinumab) showed rapid relief from symptoms of hidradenitis suppurativa (HS) as early as Week 21 As the only IL-17A inhibitor approved for HS, Cosentyx offers a meaningful new treatment option that demonstrated reductions in inflammatory nodules and abscesses, and flares2 HS is a chronic, progressive and often painful disease that may affect 1 in 100 people worldwide3,4 EAST HANOVER, N.J., Oct. 31, 2023 /PRNewswire/ -- Novartis, a global leader in immuno-dermatology and rheumatology, announced today that the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults. Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine believed to be involved in the inflammation of HS.2 HS is a chronic, systemic and often painful skin disease that causes recurring boil-like lumps that may burst into open wounds and cause irreversible scarring, often in the most intimate parts of the body.3 It may take people living with HS an average of up to 10 years to get a correct diagnosis, which can result in disease progression and significantly impact their quality of life.5,6 Until now, there has been only one biologic approved to treat HS.7 "For many patients, the daily impact of HS and the search for symptom relief can last years – which can come with painful, irreversible physical and emotional scarring," said Alexa B. Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE trials, Professor of Dermatology at Harvard Medical School, President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston. "This approval marks an important milestone for countless patients who have been faced with limited treatment possibilities and who now have a new option." "HS is one of the most devastating and exhausting skin diseases. The pain of flares can be debilitating and limits my ability to work or participate in social activities. It can have a major impact on me physically and emotionally, including feelings of anxiety, stress and isolation," said Donna Atherton, EdD, Founder and Chief Mission Officer, International Association of Hidradenitis Suppurativa Network (IAHSN). "The approval of a new treatment option brings fresh hope to me and the HS community that we may find relief from the burden of the disease." The FDA approval was based on analyses from the largest Phase III program in HS to date, SUNSHINE and SUNRISE, in which a higher proportion of patients given Cosentyx 300 mg either every two weeks or every four weeks achieved a Hidradenitis Suppurativa Clinical Response (HiSCR50) compared to placebo.1 Cosentyx for HS is approved as a 300 mg dose, administered every four weeks, with the option to increase to every two weeks if the patient has an inadequate response.1 In both the SUNSHINE and SUNRISE studies, which evaluated Cosentyx across 16-week (vs placebo) and 52-week treatment periods, the onset of action of Cosentyx occurred as early as Week 2.1 Efficacy progressively increased to Week 16 and was observed up to Week 52.2 The safety profile of Cosentyx observed in these HS trials was consistent with its known safety profile observed in the plaque psoriasis trials, affirming the differentiated safety profile of Cosentyx.1 "Cosentyx can offer effective, lasting relief from HS symptoms so that people with HS have a chance to live every day with confidence," said Victor Bultó, President, Novartis US. "With this sixth indication approval for Cosentyx – along with ongoing studies in numerous other conditions – we are reaffirming our commitment to reimagine medicine for those living with immunological diseases." About the SUNSHINE and SUNRISE trials2 The SUNSHINE (NCT03713619) and SUNRISE (NCT03713632) trials comprise the largest Phase III program in hidradenitis suppurativa (HS), with a combined enrollment of more than 1,000 patients. SUNSHINE and SUNRISE are identical, global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies that evaluated the short- (16 weeks) and long-term (up to 52 weeks) efficacy, safety and tolerability of two dose regimens of Cosentyx in adults with moderate to severe HS. A Hidradenitis Suppurativa Clinical Response (HiSCR50), the primary endpoint in the two pivotal trials, is defined as at least a 50% decrease in abscess and inflammatory nodule (AN) count with no increase in the number of abscesses and/or draining tunnels. Secondary endpoints included a decrease in abscess and inflammatory nodules by at least 50% (AN50), the proportion of patients experiencing a flare, and the proportion of patients with a skin pain numeric rating scale 30 response up to 16 weeks of treatment.2 Results from the US Food and Drug Administration (FDA)-requested analyses at Week 16 showed that a significantly higher proportion of patients achieved HiSCR50 when treated with Cosentyx 300 mg dosed every two weeks (after standard weekly loading doses), compared with placebo in both the SUNSHINE and SUNRISE trials (44.5% vs 29.4% [*P<0.05] and 38.3% vs 26.1% [*P<0.05], respectively).1 A greater proportion of patients randomized to Cosentyx 300 mg dosed every four weeks (after standard weekly loading doses) achieved HiSCR50 compared with placebo in both SUNSHINE (41.3% vs 29.4%) and SUNRISE (42.5% vs 26.1% [*P<0.05]) trials.1 An exploratory analysis assessed the long-term effects of Cosentyx for each of the primary and secondary endpoints for up to 52 weeks. HiSCR values observed at Week 16 following either dose regimen of Cosentyx were improved over time to Week 52 (SUNSHINE: SECQ2W [56.4%]; SECQ4W [56.3%]; SUNRISE: SECQ2W [65.0%]; SECQ4W [62.2%]), with rapid improvements seen in patients who switched from placebo at Week 16.8 *Statistically significant versus placebo based on the pre-defined hierarchy (from the pre-specified primary statistical analysis) with overall alpha = 0.05 (two-sided). About Cosentyx® (secukinumab) Cosentyx is the first and only fully human biologic that specifically targets and blocks interleukin-17A (IL-17A), an important cytokine involved in the inflammation of psoriatic arthritis (PsA), moderate to severe plaque psoriasis, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).9,10 Cosentyx is a proven medicine and has been studied clinically for more than 14 years. The medicine is backed by robust evidence, including 8 years of real-world data in adults and 5 years of long-term safety and efficacy across moderate to severe plaque psoriasis, PsA and AS.11-17 These data strengthen the position of Cosentyx as a treatment across AS, nr-axSpA, PsA, moderate to severe plaque psoriasis (adult and pediatric) and two subtypes of juvenile idiopathic arthritis (JIA), enthesitis-related arthritis and juvenile psoriatic arthritis.1 More than 1 million patients have been treated with Cosentyx worldwide since its launch in 2015.18 Cosentyx is approved in more than 100 countries, most recently gaining approval for JIA and HS in the US and Europe.19,20 INDICATIONS COSENTYX® (secukinumab) is a prescription medicine used to treat: people 6 years of age and older with moderate to severe plaque psoriasis (PsO) that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light alone or with systemic therapy) people 2 years of age and older with active psoriatic arthritis (PsA) adults with active ankylosing spondylitis (AS) adults with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation people 4 years of age and older with active enthesitis-related arthritis (ERA) adults with moderate to severe hidradenitis suppurativa (HS) IMPORTANT SAFETY INFORMATION Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients. What is the most important information I should know about COSENTYX? COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as: Infections COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have died from these infections. Your doctor should check you for tuberculosis (TB) before starting treatment with COSENTYX. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX. Your doctor should watch you closely for signs and symptoms of TB during treatment with COSENTYX. Do not use COSENTYX if you have an active TB infection. Before starting COSENTYX, tell your doctor if you: are being treated for an infection 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 think you have an infection or have symptoms of an infection such as: fevers, sweats, or chills; muscle aches; cough; shortness of breath; blood in your phlegm; weight loss; warm, red, or painful skin or sores on your body; diarrhea or stomach pain; burning when you urinate or urinate more often than normal After starting COSENTYX, call your doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor. What are the possible side effects of COSENTYX? COSENTYX may cause serious side effects, including: Serious allergic reactions Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; skin rash or hives (red, itchy bumps). If you have a severe allergic reaction, do not give another injection of COSENTYX. Inflammatory bowel disease New cases of inflammatory bowel disease or "flare-ups" can happen with COSENTYX, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn's disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea. Severe skin reactions that look like eczema can happen during treatment with COSENTYX from days to months after your first dose and can sometimes lead to hospitalization. Your doctor may temporarily stop treatment with COSENTYX if you develop severe skin reactions. Tell your doctor if you have any of the following signs or symptoms: redness or rash; itching; small bumps or patches; your skin is dry or feels like leather; blisters on the hands or feet that ooze or become crusty or skin peeling. The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory tract infections. These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects. Before using COSENTYX, tell your doctor if you: have any of the conditions or symptoms listed above for infections. have inflammatory bowel disease (Crohn's disease or ulcerative colitis). are allergic to latex. The needle cap on the COSENTYX Sensoready® pen, and 150 mg/mL and 75 mg/0.5 mL prefilled syringes contains latex. have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines. Children should be brought up to date with all vaccines before starting COSENTYX. have any other medical conditions and all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your doctor should decide if you will use COSENTYX. are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. Please click here for Cosentyx full Prescribing Information. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References Cosentyx Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals Corp; October 2023. Kimball AB, Jemec GBE, Alavi A, et al. Secukinumab in moderate to severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and 52 results of two identical, double-blind, placebo-controlled, phase 3 randomised trials. Lancet. 2023; published online Feb 3. Available at: (23)00022-3 [Last accessed: February 2023]. MedLine Plus. Hidradenitis suppurativa [online]. Available at: [Last accessed: March 2022]. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6:18. Doi: 10.1038/s41572-020-0149-1 Kokolakis G, Wolk K, Schneider-Burrus S, et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology. 2020;236:421-430. Kimball AB, Okun MM, Williams DA, et al. Two phase 3 trials of adalimumab for hidradenitis suppurativa. N Engl J Med. 2016;375:422-434. Martora F, Megna M, Battista T, et al. Adalimumab, Ustekinumab, and Secukinumab in the Management of Hidradenitis Suppurativa: A Review of the Real-Life Experience. Clin Cosmet Investig Dermatol. 2023;16:135-148. Published 2023 Jan 19. Doi:10.2147/CCID.S391356 4. Kimball AB, Jemec GBE, Alavi A, et al. Efficacy and Safety of Secukinumab in Patients with Moderate to Severe Hidradenitis Suppurativa from the Phase 3 SUNSHINE and SUNRISE Trials. Poster presented at American Academy of Dermatology (AAD) 2023 Annual Meeting; March 17-21, 2023, New Orleans, LA. Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24. McGonagle DG, McInnes IB, Kirkham BW, et al. The role of IL-17A in axial spondyloarthritis and psoriatic arthritis: recent advances and controversies. Annals Rheum Dis. 2019;78:1167-1178. Baraliakos X, Braun J, Deodhar A, et al. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD Open. 2019;5:e001005. Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32:1507-1514. Mease PJ, Kavanaugh A, Reimold A, et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study. ACR Open Rheumatol. 2020;2:18-25. Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. Novartis Pharmaceuticals Corp; July 23, 2018. Data on file. CAIN457F2310 and CAIN457F2305 summary of 5-year clinical safety in (ankylosing spondylitis). Novartis Pharmaceuticals Corp; May 2019. Data on file. CAIN457F2312 Data Analysis Report. Novartis Pharmaceuticals Corp; November 2008. McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;386:1137-46. Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; January 2023. Novartis AG. 2021. Novartis Cosentyx® receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. [Press release]. Available at: [Last accessed: February 2023]. Novartis Europharm Limited. Cosentyx® (secukinumab): Summary of Product Characteristics. Available at: [Last accessed: July 2023]. # # # SOURCE Novartis Pharmaceuticals Corporation

First new intravenous (IV) treatment option in six years for adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)1-6 Cosentyx® (secukinumab) administered via IV infusion offers healthcare providers choice and flexibility to tailor treatment to their patients' unique needs With both IV and subcutaneous formulations, Cosentyx can now help a broader range of PsA, AS and nr-axSpA patients manage their condition EAST HANOVER, N.J., Oct. 6, 2023 /PRNewswire/ -- Novartis, a global leader in immuno-dermatology and rheumatology, announced today that the US Food and Drug Administration (FDA) has approved an intravenous (IV) formulation of Cosentyx® (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). Cosentyx is the only treatment approved in an IV formulation that specifically targets and blocks interleukin-17A (IL-17A), and the only non-tumor necrosis factor alpha (TNF-α) IV option available in all these indications. The IV formulation of Cosentyx offers patients a monthly 30-minute, weight-based dosing option, requiring no pre-medication and no lab monitoring.1 The new IV administration option will be available in Q4 of 2023. "A significant portion of the millions of PsA, AS and nr-axSpA patients in the US require treatment through IV infusions for a variety of reasons, including not being comfortable with self-injections or simply preferring to have treatments administered in their healthcare provider's office," said Philip J. Mease, M.D., Clinical Professor at the University of Washington School of Medicine and Director of Rheumatology Research at the Swedish Medical Center in Seattle, WA. "The approval of Cosentyx as an IV formulation is an important milestone for patients because it expands the treatment options available to them with a different mechanism of action than existing biologic IV therapies, along with the comfort and familiarity of an established treatment." "At Novartis, we are committed to ensuring healthcare providers and patients have treatment options available to meet their unique needs. With this approval of Cosentyx as an IV formulation, along with the subcutaneous formulation, we can broaden the use of Cosentyx to help more patients manage their condition with a medicine backed by more than a decade of clinical research and eight years of real-world experience," said Christy Siegel, Vice President and Head of Immunology, Novartis US. About Cosentyx ® (secukinumab) Cosentyx is a fully human biologic that specifically targets and blocks interleukin-17A (IL-17A), an important cytokine involved in the inflammation of psoriatic arthritis (PsA), moderate to severe plaque psoriasis, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).7,8 Cosentyx is a proven medicine and has been studied clinically for more than 14 years. The medicine is backed by robust evidence, including 8 years of real-world data in adults and 5 years of long-term safety and efficacy in adults with moderate to severe plaque psoriasis, PsA and AS.1,9-15 These data strengthen the position of Cosentyx as a treatment across AS, nr-axSpA, PsA, moderate to severe plaque psoriasis (adult and pediatric) and two subtypes of juvenile idiopathic arthritis (JIA), enthesitis-related arthritis and juvenile psoriatic arthritis.1 More than 1 million patients have been treated with Cosentyx worldwide since its launch in 2015.16 Cosentyx is approved in more than 100 countries, most recently gaining approval for JIA and hidradenitis suppurativa in Europe.17-20 INDICATIONS COSENTYX® (secukinumab) is a prescription medicine used to treat: people 6 years of age and older with moderate to severe plaque psoriasis (PsO) that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light alone or with systemic therapy) people 2 years of age and older with active psoriatic arthritis (PsA) adults with active ankylosing spondylitis (AS) adults with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation people 4 years of age and older with active enthesitis-related arthritis (ERA) IMPORTANT SAFETY INFORMATION Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients. What is the most important information I should know about COSENTYX? COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as: Infections COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have died from these infections. Your doctor should check you for tuberculosis (TB) before starting treatment with COSENTYX. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX. Your doctor should watch you closely watch for signs and symptoms of TB during treatment with COSENTYX. Do not take COSENTYX if you have an active TB infection. Before starting COSENTYX, tell your doctor if you: are being treated for an infection 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 think you have an infection or have symptoms of an infection such as: fevers, sweats, or chills; muscle aches; cough; shortness of breath; blood in your phlegm; weight loss; warm, red, or painful skin or sores on your body; diarrhea or stomach pain; burning when you urinate or urinate more often than normal After starting COSENTYX, call your doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor. What are the possible side effects of COSENTYX? COSENTYX may cause serious side effects, including: Inflammatory bowel disease New cases of inflammatory bowel disease or "flare-ups" can happen with COSENTYX and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn's disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea. Serious allergic reactions Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; skin rash or hives (red, itchy bumps). If you have a severe allergic reaction, do not give another injection of COSENTYX. Severe skin reactions that look like eczema can happen during treatment with COSENTYX from days to months after your first dose and can sometimes lead to hospitalization. Your healthcare provider may temporarily stop treatment with COSENTYX if you develop severe skin reactions. Tell your healthcare provider if you have any of the following signs or symptoms: redness or rash, itching, small bumps or patches, your skin is dry or feels like leather, blisters on the hands or feet that ooze or become crusty and skin peeling. The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory infections. These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects. Before using COSENTYX, tell your doctor if you: have any of the conditions or symptoms listed above for infections. have inflammatory bowel disease (Crohn's disease or ulcerative colitis). are allergic to latex. The needle cap on the COSENTYX Sensoready® pen, and 150 mg/mL and 75 mg/0.5 mL prefilled syringes contains latex. have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines. Children should be brought up to date with all vaccines before starting COSENTYX. have any other medical conditions and all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your doctor should decide if you will use COSENTYX. are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please click here for Cosentyx full Prescribing Information. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References Cosentyx Prescribing Information. East Handover, NJ: Novartis Pharmaceuticals Corp; October 2023. Taltz Prescribing Information. Indianapolis, IN: Eli Lilly and Company; September 2022. Siliq Prescribing Information. Bridgewater, NJ: Bausch Health US, LLC; April 2020. Remicade Prescribing Information. Horsham, PA: Janssen Biotech, Inc; October 2021. Orencia Prescribing Information. Princeton, NJ: Bristol Meyers Squibb Company; December 2021. Simponi Aria Prescribing Information. Horsham, PA: Janssen Biotech, Inc; February 2021. Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24. McGonagle DG, McInnes IB, Kirkham BW, et al. The role of IL-17A in axial spondyloarthritis and psoriatic arthritis: recent advances and controversies. Annals Rheum Dis. 2019;78:1167-1178. Baraliakos X, Braun J, Deodhar A, et al. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD Open. 2019;5:e001005. Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). 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