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Novartis Pharma AG <\/p>\n Novartis Pharma AG <\/p>\n
Cosentyx is the only IL-17A inhibitor approved for this population, and the first differentiated mechanism in nearly a decade1-3\u00a0<\/p>\n
HS often\u00a0emerges\u00a0around puberty, underscoring importance of early\u00a0diagnosis and\u00a0intervention\u00a0with biologics\u00a0to help reduce long-term disease burden4-6\u00a0<\/p>\n
Approval marks fourth pediatric\u00a0indication\u00a0for Cosentyx, reinforcing its robust safety and efficacy profile1\u00a0<\/p>\n
Basel, March 13, 2026 \u2013 Novartis announced today that Cosentyx\u00ae\u00a0(secukinumab) received US Food and Drug Administration (FDA) approval for treating\u00a0pediatric\u00a0patients\u00a012 years and older with moderate to severe hidradenitis suppurativa (HS),\u00a0making it the only IL-17A inhibitor for this population1.\u00a0The approval of a distinct biologic option for\u00a0pediatric patients\u00a0living\u00a0with HS\u00a0allows treatment to be tailored to the individual and establishes Cosentyx\u00a0as\u00a0a meaningful addition to the treatment landscape1-13.<\/p>\n
\u201cHidradenitis suppurativa\u00a0(HS)\u00a0often begins in adolescence and\u00a0can cause irreversible scarring and\u00a0disabilities,\u201d\u00a0said Alexa B. Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE clinical\u00a0trials\u00a0in adult HS patients, President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston, and\u00a0Professor of Dermatology\u00a0at Harvard Medical School. \u201cThe approval of\u00a0Cosentyx\u00a0represents\u00a0an important advancement\u00a0for younger\u00a0HS\u00a0patients who\u00a0have\u00a0had limited treatment options.\u201d<\/p>\n
HS is a chronic, systemic inflammatory skin disease that causes recurring boil-like lesions, which can rupture into painful wounds and lead to scarring7.\u00a0HS affects as many as\u00a01 in 100 people worldwide and often begins around puberty7.\u00a0 More than half of patients develop symptoms during adolescence, highlighting the importance of early intervention5,6.<\/p>\n
\u201cHidradenitis suppurativa (HS) affects far more than skin; it impacts confidence, emotional well-being and relationships during a formative period for many pediatric patients,\u201d said Brindley Brooks, Founder & CEO, HS Connect. \u201cFor families watching their children struggle, this FDA approval brings hope for earlier intervention.\u201d<\/p>\n
The distinct IL-17A mechanism\u00a0provides\u00a0physicians\u00a0with a differentiated therapeutic option to help manage this challenging condition in younger patients, with dosing tailored to patient weight1.\u00a0\u00a0The\u00a0use of Cosentyx in patients\u00a0aged\u00a012+\u00a0with\u00a0moderate to severe HS\u00a0weighing\u00a030 kg or more\u00a0is\u00a0supported by\u00a0well-controlled adult\u00a0studies\u00a0and pharmacokinetic modeling extrapolated from\u00a0adult HS and psoriasis clinical trials, as well as pediatric clinical trial data from other approved indications1.\u00a0The approval\u00a0is also\u00a0supported by\u00a0dosing analysis,\u00a0which\u00a0predicted that weight-based dosing of\u00a0Cosentyx\u00a0in pediatric patients can provide similar exposure to adult HS patients1.<\/p>\n
Story Continues <\/p>\n
\u201cWith more than a decade of real-world experience across multiple autoimmune diseases, Cosentyx is a well-established treatment option that many physicians trust,\u201d said Victor Bult\u00f3, President, Novartis US. \u201cYet 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.\u201d\u00a0 <\/p>\n
About Cosentyx\u00ae (secukinumab)
Cosentyx is a fully human\u00a0biologic\u00a0that 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\u00a0hidradenitis suppurativa (HS),\u00a0psoriatic 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\u00a0HS,\u00a0PsO, enthesitis-related arthritis (ERA), and juvenile psoriatic arthritis (JPsA)11,12. Cosentyx is supported by robust evidence and\u00a0more than\u00a010 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\u00a01.8 million patients\u00a0worldwide\u00a0and is now approved in over 100 countries13.<\/p>\n
About hidradenitis suppurativa (HS)\u00a0
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,\u00a0and\u00a0may 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,\u00a023.<\/p>\n
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 \u201cpotential,\u201d \u201ccan,\u201d \u201cwill,\u201d \u201cplan,\u201d \u201cmay,\u201d \u201ccould,\u201d \u201cwould,\u201d \u201cexpect,\u201d \u201canticipate,\u201d \u201clook forward,\u201d \u201cbelieve,\u201d \u201ccommitted,\u201d \u201cinvestigational,\u201d \u201cpipeline,\u201d \u201claunch,\u201d 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\u2019s 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.<\/p>\n
About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people\u2019s 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.<\/p>\n
Reimagine medicine with us: Visit us at https:\/\/www.novartis.com<\/a> and connect with us on LinkedIn<\/a>, Facebook<\/a>, X\/Twitter<\/a> and Instagram<\/a>.<\/p>\n References<\/p>\n Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.<\/p>\n Humira.\u00a0Prescribing\u00a0Information.\u00a0AbbVie\u00a0Inc.<\/p>\n Celltrion, Inc.\u00a0FDA approves expanded pediatric indications for\u00a0YUFLYMA\u00ae\u00a0(adalimumabaaty) and unbranded adalimumabaaty\u00a0in the United States. Press release. Celltrion; October\u00a017,\u00a02025. Available from: https:\/\/www.celltrion.com\/en-us\/company\/media-center\/press-release\/4207<\/a>. [Last accessed: February\u00a05,\u00a02026].<\/p>\n Ingram JR. The epidemiology of hidradenitis suppurativa.\u00a0Br J Dermatol. 2020;183(6):990-998. doi:10.1111\/bjd.19435<\/p>\n Molina-Leyva A, Cuenca-Barrales C. Adolescent-onset hidradenitis suppurativa: prevalence, risk\u00a0factors\u00a0and disease features.\u00a0Dermatology. 2019;235(1):45-50. doi:10.1159\/000493465<\/p>\n Hallock KK, Mizerak MR, Dempsey A, Maczuga S, Kirby JS. Differences between children and adults with hidradenitis suppurativa.\u00a0JAMA Dermatol. 2021;157(9):1095-1101. doi:10.1001\/jamadermatol.2021.2865<\/p>\n MedLine\u00a0Plus. Hidradenitis suppurativa [online]. Available from: https:\/\/medlineplus.gov\/genetics\/condition\/hidradenitis-suppurativa\/<\/a> [Last accessed: January 2026].<\/p>\n Novartis\u00a0Europharm\u00a0Limited. Cosentyx\u00ae (secukinumab): Summary of Product Characteristics. Available at:\u00a0https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/cosentyx-epar-product-information_en.pdf<\/a>\u00a0[Last accessed:\u00a0February\u00a02026].<\/p>\n Girolomoni\u00a0G,\u00a0Mrowietz\u00a0U and Paul C. Psoriasis: rationale for targeting interleukin-17.\u00a0Br J Dermatol\u00a02012; 167: 717-724.<\/p>\n 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<\/a> [Last accessed:\u00a0February 2026].<\/p>\n Novartis Cosentyx receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. [Press release]. Available at:\u00a0https:\/\/www.novartis.com\/news\/media-releases\/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-enthesitis-related-arthritis-and-psoriatic-arthritis<\/a>\u00a0[Last accessed:\u00a0February 2026].<\/p>\n Novartis Cosentyx receives positive CHMP opinion for expanded use in childhood arthritic conditions. [Press release]. Available at:\u00a0https:\/\/www.novartis.com\/news\/media-releases\/novartis-cosentyx-secukinumab-receives-positive-chmp-opinion-expanded-use-childhood-arthritic-conditions<\/a>\u00a0[Last accessed:\u00a0February 2026].<\/p>\n Data on\u00a0file. Cosentyx\u00a0WW LTD patients Q1’25.<\/p>\n Uta Kiltz et al.\u00a0Secukinumab\u00a0Retention 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<\/a>]<\/p>\n