Novartis Receives Positive CHMP Opinion for Cosentyx® in Adolescents aged 12+ with Hidradenitis Suppurativa (HS)

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Basel, November 13, 2026 – Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization of Cosentyx® (secukinumab) for adolescents aged 12 years and older with active moderate to severe hidradenitis suppurativa (HS) who have had an inadequate response to conventional systemic HS therapy.6 If approved by the European Commission (EC), Cosentyx would become the only interleukin-17A (IL-17A) inhibitor approved for adolescent HS in Europe and the first innovative biologic treatment option for this population in nearly a decade, addressing a significant unmet need where treatment options remain limited.1,2,7,8

HS is a chronic, systemic, progressive and often painful inflammatory skin disease.5,9 It causes recurring boil-like abscesses that can burst, creating open wounds, often in the most intimate parts of the body, which may result in irreversible scarring.5,8-10 More than 50% of cases begin during puberty.4,5

“Hidradenitis suppurativa often begins during adolescence, a critical period when the disease can progress to irreversible scarring, yet we currently have limited treatment options for this age group,” said Dr. John Ingram, Clinical Professor, Cardiff University School of Medicine, United Kingdom. “This positive CHMP opinion for secukinumab represents an important step toward addressing a meaningful gap in care for young people living with this challenging disease.”

The CHMP positive opinion is based on evidence demonstrating that weight-based dosing in adolescents aged 12 years and older provides Cosentyx exposure generally comparable to that observed in adults with HS.2 This includes efficacy and safety data from adult HS clinical studies, pharmacokinetic modeling extrapolated from adult HS and psoriasis clinical trials, pediatric clinical trial data from other approved Cosentyx indications, and weight-based dosing analyses.2,11–14 The safety profile of Cosentyx is well-established across several approved adult and pediatric indications.2,15-17

“For over a decade, Cosentyx has helped transform outcomes across several immune-mediated diseases, including hidradenitis suppurativa. Adolescents living with moderate to severe HS deserve access to more advanced treatment options,” said Patrick Horber, President, International, Novartis. “This positive CHMP opinion brings us closer to that goal in Europe, and we look forward to the European Commission decision in the coming months.”

The EC is expected to issue a final decision within approximately two months, following today’s CHMP opinion.

 

About Cosentyx

Cosentyx is a fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases.18,19 It is approved for use in adults with psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), hidradenitis suppurativa (HS), and polymyalgia rheumatica (PMR).2,19–21 Cosentyx is also approved for use in pediatric patients, including those with PsO, juvenile idiopathic arthritis subtypes such as juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA), and in the U.S. for pediatric patients aged 12 years and older with moderate to severe HS and for juvenile AS.2,12-14,19,22,23

 

About Novartis in Immunology

At Novartis, we’re advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with complex, and often overlooked autoimmune and other immune-mediated diseases, so they can reclaim their lives. Building on our legacy of first-in-class innovation across rheumatology, dermatology and allergy, and a diverse industry-leading pipeline, we’re committed to shaping what’s next in Immunology.

 

About Novartis

Novartis is an 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 300 million people worldwide.

Reimagine medicine with us: Visit us at www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

 

References

  1. European Medicines Agency. Search results for “hidradenitis suppurativa.” European Medicines Agency. https://www.ema.europa.eu/en/search?search_api_fulltext=polymyalgia%20rheumatica&keywords=allwords&keyword=hidradenitis%20suppurativa%20&f%5B0%5D=is_document%3ADocument&page=0  [Last Accessed: November 2026].
  2. Novartis Europharm Limited. Cosentyx® (secukinumab): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf [Last Accessed: November 2026].
  3. MedLine Plus. Hidradenitis suppurativa [online]. Available from: https://medlineplus.gov/genetics/condition/hidradenitis-suppurativa/ [Last accessed: November 2026].
  4. Molina-Leyva A, Cuenca-Barrales C. Adolescent-onset hidradenitis suppurativa: prevalence, risk factors and disease features. Dermatology. 2019;235(1):45-50. doi:10.1159/000493465
  5. Hallock KK, Mizerak MR, Dempsey A, Maczuga S, Kirby JS. Differences between children and adults with hidradenitis suppurativa. JAMA Dermatol. 2021;157(9):1095-1101. doi:10.1001/jamadermatol.2021.2865
  6. European Medicines Agency (EMA). Cosentyx, INN-secukinumab: CHMP post-authorisation summary of positive opinion. European Medicines Agency; 2026. Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cosentyx-vr-0000340032_en.pdf. [Last Accessed November 13, 2026]
  7. AbbVie. AbbVie’s HUMIRA® (Adalimumab) Receives CHMP Positive Opinion to Treat Adolescents with Hidradenitis Suppurativa, a Chronic Inflammatory Skin Disease. Available at: https://news.abbvie.com/2016-11-14-AbbVies-HUMIRA-Adalimumab-Receives-CHMP-Positive-Opinion-to-Treat-Adolescents-with-Hidradenitis-Suppurativa-a-Chronic-Inflammatory-Skin-Disease [Last Accessed: November 2026].
  8. European Medicines Agency. Biosimilar medicines: Overview. Available at: https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview [Last Accessed: November 2026].
  9. Garg A, Naik HB, Alavi A, et al. Real-World Findings on the Characteristics and Treatment Exposures of Patients with Hidradenitis Suppurativa from US Claims Data. Dermatol Ther (Heidelb). 2023 Feb;13(2):581-594. doi: 10.1007/s13555-022-00872-1.
  10. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers 2020; 6: 18.
  11. Kimball AB, Jemec GBE, Alavi A, et al. Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials. Lancet 2023; 401: 747-761.
  12. Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-moderate-severe-plaque-psoriasis [Last Accessed: November 2026].
  13. Novartis Cosentyx receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-enthesitis-related-arthritis-and-psoriatic-arthritis [Last Accessed: November 2026].
  14. Novartis Cosentyx receives positive CHMP opinion for expanded use in childhood arthritic conditions. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-secukinumab-receives-positive-chmp-opinion-expanded-use-childhood-arthritic-conditions [Last Accessed: November 2026].
  15. Mease PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, Geusens P, Pascale P, Delicha EM, Pricop L, Mpofu S. “Secukinumab Provides Sustained Improvements in the Signs and Symptoms in Psoriatic Arthritis: Final 5-Year Efficacy and Safety Results from a Phase 3 Trial”. ACR/ARHP 2020 Annual Meeting Abstract. Presented in ACR Open Rheumatology (2020); CONCL00511.
  16. McInnes IB, Mease PJ, Kivitz AJ, Nash P, Rahman P, Rech J, Conaghan PG, Kirkham B, Navarra S, Belsare AD, Delicha EM, Pricop L, Mpofu S; FUTURE 2 Study Group. “Long-term efficacy and safety of secukinumab in patients with psoriatic arthritis: 5-year (end of study) results from the phase III FUTURE 2 study.” Lancet Rheumatology. 2020; 2(4): e227–e235.
  17. Bissonnette R, Luger T, Thaçi D, Toth D, Lacombe A, Xia S, Mazur R, Patekar M, Charef P, Milutinovic M, Leonardi C, Mrowietz U. 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 Sep;32(9):1507–1514.
  18. Novartis receives European approval for Cosentyx® as first and only IL-17A inhibitor for hidradenitis suppurativa. Available at: https://www.novartis.com/news/media-releases/novartis-receives-european-approval-cosentyx-first-and-only-il-17a-inhibitor-hidradenitis-suppurativa [Last accessed: November 2026].
  19. Girolomoni G, Mrowietz U, Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167(4):717–724.
  20. Novartis Cosentyx shows clinically meaningful symptom improvements in patients with hidradenitis suppurativa. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-shows-clinically-meaningful-symptom-improvements-patients-hidradenitis-suppurativa-pivotal-phase-iii-trials [Last Accessed: November 2026].
  21. Novartis receives European Commission approval for Cosentyx® in polymyalgia rheumatica (PMR). [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-receives-european-commission-approval-cosentyx-polymyalgia-rheumatica-pmr [Last Accessed: November 2026].
  22. Novartis. Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-pediatric-patients-aged-12-moderate-severe-hidradenitis-suppurativa [Last Accessed: November 2026].
  23. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp. Available at: https://www.novartis.com/us-en/sites/novartis_us/files/cosentyx.pdf [Last Accessed: November 2026].

 

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