Novartis Cosentyx® receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis

New approvals are based on JUNIPERA trial data showing Cosentyx® (secukinumab) demonstrated reduced flare risk versus placebo and improvement in disease activity observed over two years across both enthesitis-related arthritis (ERA) and psoriatic arthritis (PsA) in pediatric patients1 Safety in these pediatric populations was consistent with the known safety profile of Cosentyx2 Cosentyx is the only biologic treatment approved for children and adolescents for both ERA (4 years of age and older) and PsA (2 years of age and older) in the US Basel, December 22, 2021 — Novartis, a leader in rheumatology and immuno-dermatology, today announced the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in four years and older, and active juvenile psoriatic arthritis (JPsA) in patients two years and older1. Cosentyx is now the first biologic indicated for ERA, and the only biologic treatment approved for both ERA and PsA in pediatric patients in the US. These are the second and third approvals for Cosentyx in a pediatric population in the US, and Cosentyx now has a total of five indications across rheumatology and dermatology1. “Prior research suggests that despite receiving treatment, some children and adolescents with PsA or ERA can continue to experience symptoms,” said Hermine Brunner, M.D., Cincinnati Children’s Hospital. “The findings from the Phase III JUNIPERA trial show that pediatric patients treated with secukinumab demonstrated marked responses throughout the treatment period. This approval is positive news for some patients who continue to struggle with painful symptoms like inflammation of the joints and swollen fingers and toes.” ERA and JPsA, subtypes of juvenile idiopathic arthritis (JIA), are autoimmune diseases3-5. ERA is characterized by joint swelling and pain where tendons and ligaments attach to bone and may present with low back pain or tenderness at the palpation of the hips5. JPsA is characterized by joint swelling and skin psoriasis and may present with nail changes, inflammation of fingers and/or toes or psoriatic skin changes in a first-degree relative6. If left untreated, they can lead to high levels of pain and disability3-5. “This marks the second and third US pediatric approval this year for Cosentyx, following pediatric psoriasis approval and further reinforces the proven efficacy and safety of the therapy. With more than 500,000 adult and pediatric patients treated worldwide since launch, healthcare professionals and patients can feel confident in Cosentyx,” said Todd Fox, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis. “Furthermore, we are pleased to build on our strong heritage of bringing innovative treatments to young people living with rheumatic diseases, which began with the FDA approval of Ilaris. We are committed to bringing Cosentyx to this pediatric community globally as part of our ambition to expand Cosentyx to 10 indications in areas of high unmet need.” The approved pediatric dosing for Cosentyx in children and adolescents is 75 mg (15 kg or more to less than 50 kg) or 150 mg (50 kg or more)1. It is administered as a subcutaneous injection by a pre-filled syringe or Sensoready® pen every 4 weeks after initial loading doses1. With appropriate guidance/instruction from a healthcare professional, Cosentyx can be administered by an adult caregiver outside of a healthcare provider’s office via a single-dose prefilled syringe or Sensoready® pen. The approval is based on data from the Phase III JUNIPERA study, a two-year, three-part, double-blind, placebo-controlled, randomized-withdrawal trial that enrolled 86 children and adolescents aged 2 to 18 years old with a confirmed diagnosis of ERA or JPsA according to a modified International League of Associations for Rheumatology classification criteria7. The primary endpoint of the study was time to flare in the treatment period 2 (Week 12 to Week 104)7. In children and adolescents aged 2 to 18 years old, the study demonstrated that patients with active JPsA (n = 34; mean age: 12.2) treated with Cosentyx had a longer time to flare, showing an 85% reduction in the risk of flare (P<0.001) versus placebo1,8. The study also demonstrated that patients with active ERA (n = 52; mean age: 13.7) treated with Cosentyx had a significantly longer time to flare, showing a 53% reduction in the risk of flare versus placebo1,8. Safety in this pediatric population was consistent with the known safety profile of Cosentyx for the treatment of plaque psoriasis, PsA, non-radiographic axial spondyloarthritis and ankylosing spondylitis2. “The symptoms of PsA and ERA can be debilitating for children and adolescents living with these chronic conditions, impacting their daily lives,” said Tiffany Westrich-Robertson, CEO, International Foundation for Autoimmune & Autoinflammatory Arthritis (AiArthritis). “It is encouraging to see an additional treatment option for these underserved patient populations.” In July 2020, Cosentyx received EU approval as a first-line systemic treatment for pediatric psoriasis in patients aged 6 to 18 years old and recently received approval in the US and China1,9,10. In 2021, Cosentyx was also approved in Japan to treat both PsA and psoriasis in pediatric patients aged 6 years or older, as well as those with generalized pustular psoriasis11. Novartis has filed a regulatory submission for Cosentyx in ERA and JPsA in Europe with a decision anticipated in the coming months. About Cosentyx® (secukinumab)Cosentyx is the first and only fully human biologic that directly inhibits 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)12,13. Cosentyx is a proven medicine and has been studied clinically for more than 14 years. The medicine is backed by robust evidence, including 5 years of clinical data in adults supporting long-term safety and efficacy across moderate to severe plaque psoriasis, PsA and AS14-20. These data strengthen the position of Cosentyx as a treatment across AS, nr-axSpA, PsA and moderate to severe plaque psoriasis, supported by more than 500,000 patients treated worldwide since launch in 20151,21,22. DisclaimerThis 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,” “seek,” “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. 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Sign up to follow @Novartis at https://twitter.com/novartisnewsFor Novartis multimedia content, please visit https://www.novartis.com/news/media-libraryFor questions about the site or required registration, please contact [email protected] References 1.      Cosentyx [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.2.      Ruperto N, Foeldvari I, Alexeeva E, et al. Efficacy and Safety of Secukinumab in Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis: Primary Results from a Randomised, Double-blind, Placebo-controlled, Treatment Withdrawal, Phase 3 Study (JUNIPERA). Presented as a late-breaking abstract at European Alliance of Associations For Rheumatology (EULAR) Virtual Congress; June 2-5, 2021. Abstract LB0004.3.      American College of Rheumatology. Juvenile Arthritis [online] March 2019. Available from: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Juvenile-Arthritis [Last accessed: December 2021].4.      Momah T and Ray L. Juvenile idiopathic arthritis: Old disease, new tactics. J Fam Pract. 2019;68:E8-E13.5.      Weiss PF, Beukelman T, Schanberg LE, et al. Enthesitis-related arthritis is associated with higher pain intensity and poorer health status in comparison with other categories of juvenile idiopathic arthritis: the Childhood Arthritis and Rheumatology Research Alliance Registry. J Rheumatol. 2012;39:2341-2351.6.      Ravelli A, Consolaro A, Schiappapietra B, et al. The conundrum of juvenile psoriatic arthritis. Clin Exp Rheumatol. 2015;33:S40-43.7.      ClinicalTrials.gov. Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA). Available from: https://clinicaltrials.gov/ct2/show/NCT03031782 [Last accessed: December 2021].8.      Brunner H, Foeldvari I, Alexeeva E, et al. Secukinumab Treatment In Children And Adolescents with Enthesitis-Related Arthritis And Juvenile Psoriatic Arthritis: Efficacy And Safety Results From A Phase 3 Study. Presented at the American College of Rheumatology (ACR) Convergence; October 28-30, 2021. Abstract 1424.9.      Magnolo N, Kingo K, Laquer V, et al. Secukinumab treatment demonstrated high efficacy and safety in pediatric patients with moderate to severe plaque psoriasis: 52-week results from a randomized trial. Presented at the American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX) 2021; April 23-25, 2021. Poster 26680.10.      Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab efficacy and safety profile in pediatric patients with severe chronic plaque psoriasis up to one year. Presented at AAD VMX 2021; April 23-25, 2021.11.      Mix Online. Ministry of Health, Labor and Welfare approves additional indications for 12 products, etc. Addition of Enrest’s “hypertension” [online]. September 28, 2021. Available from: https://www.mixonline.jp/tabid55.html?artid=71852 [Last accessed: December 2021].12.      Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-724.13.      Novartis Europharm Limited. Cosentyx® (secukinumab): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf [Last accessed: December 2021].14.      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:e001005.15.      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;32:1507-1514.16.      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;2:18-25.17.      McInnes IB, Behrens F, Mease PJ, et al. Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial. Lancet. 2020;395:1496-1505.18.      Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. Novartis Pharmaceuticals Corp; July 23, 2018.19.      Data on file. CAIN457F2310 and CAIN457F2305 summary of 5-year clinical safety in (ankylosing spondylitis). Novartis Pharmaceuticals Corp; May 2019.20.      Data on file. CAIN457F2312 Data Analysis Report. Novartis Pharmaceuticals Corp; November 2008.21.      Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; June 2021.22.      Data on file. AIN457A2102 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2008. # # # Novartis Media RelationsE-mail: [email protected] Michael MeoNovartis US External Communications+1 862 274 5414 (direct)[email protected] Julie MasowNovartis US External Communications+1 862 579 [email protected] ClarkNovartis Pharma Communications+41 61 324 2970 (direct)[email protected]  Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: [email protected] Central North America Samir Shah+41 61 324 7944Sloan Simpson+1 862 345 4440Thomas Hungerbuehler+41 61 324 8425Alina Levchuk+1 862 778 3372Isabella Zinck+41 61 324 7188Parag Mahanti+1 973-876-4912