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 

East Hanover, 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.

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 had serious infections while taking COSENTYX, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have died from these infections.

  • Your doctor should check you for 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
  • have or have had Hepatitis B
  • 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 get 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 removable needle cap on the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) 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 www.fda.gov/medwatch, or call 1-800-FDA-1088.

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)
  • adults and children 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
  • children 4 years of age and older with active enthesitis-related arthritis (ERA)
  • adults and children 12 years of age and older with moderate to severe hidradenitis suppurativa (HS)

Please see 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 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 https://www.novartis.us and connect with us on LinkedIn US, X/Twitter US and Instagram US.

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 
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  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-cl… [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… 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-secukinu… 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) 
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