Mar 13, 2026
  • Cosentyx is the only IL-17A inhibitor approved for this population, and the first differentiated mechanism in nearly a decade1-3 

  • HS often emerges around puberty, underscoring importance of early diagnosis and intervention with biologics to help reduce long-term disease burden4-6 

  • Approval marks fourth pediatric indication for Cosentyx, reinforcing its robust safety and efficacy profile1 

Basel, March 13, 2026 – Novartis announced today that Cosentyx® (secukinumab) received US Food and Drug Administration (FDA) approval for treating pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS), making it the only IL-17A inhibitor for this population1. The approval of a distinct biologic option for pediatric patients living with HS allows treatment to be tailored to the individual and establishes Cosentyx as a meaningful addition to the treatment landscape1-13.

“Hidradenitis suppurativa (HS) often begins in adolescence and can cause irreversible scarring and disabilities,” said Alexa B. Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE clinical trials in adult HS patients, President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston, and Professor of Dermatology at Harvard Medical School. “The approval of Cosentyx represents an important advancement for younger HS patients who have had limited treatment options.” 

HS is a chronic, systemic inflammatory skin disease that causes recurring boil-like lesions, which can rupture into painful wounds and lead to scarring7. HS affects as many as 1 in 100 people worldwide and often begins around puberty7.  More than half of patients develop symptoms during adolescence, highlighting the importance of early intervention5,6.

“Hidradenitis suppurativa (HS) affects far more than skin; it impacts confidence, emotional well-being and relationships during a formative period for many pediatric patients,” said Brindley Brooks, Founder & CEO, HS Connect. “For families watching their children struggle, this FDA approval brings hope for earlier intervention.” 

The distinct IL-17A mechanism provides physicians with a differentiated therapeutic option to help manage this challenging condition in younger patients, with dosing tailored to patient weight1.  The use of Cosentyx in patients aged 12+ with moderate to severe HS weighing 30 kg or more is supported by well-controlled adult studies and pharmacokinetic modeling extrapolated from adult HS and psoriasis clinical trials, as well as pediatric clinical trial data from other approved indications1. The approval is also supported by dosing analysis, which predicted that weight-based dosing of Cosentyx in pediatric patients can provide similar exposure to adult HS patients1.

“With more than a decade of real-world experience across multiple autoimmune diseases, Cosentyx is a well-established treatment option that many physicians trust,” said Victor Bultó, President, Novartis US. “Yet for young people living with moderate to severe hidradenitis suppurativa (HS), treatment options have remained limited for far too long. Expanding Cosentyx to this population addresses a critical gap in care and underscores our focus on advancing solutions where we can make the greatest impact on outcomes.”   

About Cosentyx® (secukinumab)
Cosentyx is a fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases. It is approved for use in adults with hidradenitis suppurativa (HS), psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA)8-10, as well as in pediatric patients with HS, PsO, enthesitis-related arthritis (ERA), and juvenile psoriatic arthritis (JPsA)11,12. Cosentyx is supported by robust evidence and more than 10 years of real-world data demonstrating its long-term safety and sustained efficacy13-18. Since its launch in 2015, it has been used to treat more than 1.8 million patients worldwide and is now approved in over 100 countries13.

About hidradenitis suppurativa (HS) 
HS is a chronic, systemic, progressive and often painful inflammatory skin disease6,19. 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 scarring6,20. It can take up to 10 years on average to get a correct diagnosis, and may affect approximately 1 in 100 people globally6,21. HS impacts patients' quality of life more than any other skin disease, and people living with HS often experience comorbidities such as obesity, diabetes, arthritis and depression20,22, 23.

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 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.

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References

  1. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.  
  2. Humira. Prescribing Information. AbbVie Inc. 
  3. Celltrion, Inc. FDA approves expanded pediatric indications for YUFLYMA® (adalimumabaaty) and unbranded adalimumabaaty in the United States. Press release. Celltrion; October 17, 2025. Available from: https://www.celltrion.com/en-us/company/media-center/press-release/4207. [Last accessed: February 5, 2026]. 
  4. Ingram JR. The epidemiology of hidradenitis suppurativa. Br J Dermatol. 2020;183(6):990-998. doi:10.1111/bjd.19435 
  5. 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 
  6. 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 
  7. MedLine Plus. Hidradenitis suppurativa [online]. Available from: https://medlineplus.gov/genetics/condition/hidradenitis-suppurativa/ [Last accessed: January 2026]. 
  8. 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: February 2026]. 
  9. Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012; 167: 717-724. 
  10. 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: February 2026]. 
  11. 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: February 2026]. 
  12. 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: February 2026]. 
  13. Data on file. Cosentyx WW LTD patients Q1'25. 
  14. Uta Kiltz et al. Secukinumab Retention and Effectiveness in Patients with PsA and Radiographic Axial Spondyloarthritis: 5-year Final Results of a Prospective Real-world Study. Abstract no:2344. ACR 2024 [Link] 
  15. Ippoliti et al. Long-Term Real-World Safety Profile of Secukinumab Assessed Through a 9-Year Experience in Patients Affected by Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Results From a Multicentric Retrospective Study. Dermatologic Therapy. 2025. Article Number: 9618241 [Link] 
  16. 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 5Year Efficacy and Safety Results from a Phase 3 Trial”. ACR/ARHP 2020 Annual Meeting Abstract. Presented in ACR Open Rheumatology (2020); CONCL00511 (Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study - PubMed) 
  17. 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. “Longterm efficacy and safety of secukinumab in patients with psoriatic arthritis: 5year (endofstudy) results from the phase III FUTURE 2 study.” Lancet Rheumatology. 2020; 2(4): e227–e235. (Long-term efficacy and safety of secukinumab in patients with psoriatic arthritis: 5-year (end-of-study) results from the phase 3 FUTURE 2 study) 
  18. 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. (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) - PubMed) 
  19. 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. 
  20. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis Suppurativa. Nat Rev Dis Primers. 2020;6 18. doi: 10.1038/s41572-020-0149-1. 
  21. 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(5):421-430. doi: 10.1159/000508787 
  22. Mac Mahon J, Kirthi S, Byrne N, et al. An Update on Health-Related Quality of Life and Patient-Reported Outcomes in Hidradenitis Suppurativa. Patient Relat Outcome Meas. 2020;11:21-26. doi: 10.2147/PROM.S174299. 
  23. Montero-Vílchez T, Sánchez-Díaz M, Martínez-López A, et al. Quality of Life in Patients with Skin Disease and Their Cohabitants. In: Jasneth M, Sage A, Medhane C, Eds. Health-Related Quality of Life. Rijeka: IntechOpen; 2021: Ch. 5. 

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