Novartis AG (NVS) announced that the U.S. FDA has approved Cosentyx for pediatric patients aged 12 and older with moderate to severe hidradenitis suppurativa. The decision makes Cosentyx the first IL-17A inhibitor available for this younger population.
Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that causes painful, boil-like lesions that can rupture and lead to scarring. The disease often begins around puberty, and more than half of patients experience symptoms during adolescence, underscoring the need for earlier diagnosis and treatment options.
Cosentyx (secukinumab), already approved for adults with HS, is now cleared for use in adolescents weighing 30 kg or more. The approval is supported by data extrapolated from adult clinical trials, pharmacokinetic modeling, and pediatric studies from other Cosentyx indications. According to Novartis, weight-based dosing in adolescents is expected to provide drug exposure levels similar to those seen in adults.
Alexa B. Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE clinical trials in adult HS patients, noted that HS can cause irreversible scarring and disability, and that the availability of Cosentyx represents an important advancement for younger patients who have limited treatment options. Patient advocacy groups also highlighted the emotional and social impact of HS on adolescents, emphasizing the significance of earlier intervention.
Cosentyx is a fully human biologic that targets interleukin-17A, a key driver of inflammation in several autoimmune diseases. It has been used globally for more than a decade and is approved for multiple adult and pediatric conditions, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile psoriatic arthritis. More than 1.8 million patients worldwide have been treated with Cosentyx since its launch in 2015.
Victor Bultó, President, Novartis US, stated that expanding Cosentyx to adolescents with HS addresses a long-standing gap in care and aligns with the company's focus on inflammatory diseases.
Cosentyx generated $6.7 billion in full-year 2025 sales, representing an 8% increase from $6.14 billion in 2024, reflecting continued steady growth across its immunology portfolio.
HS affects approximately 1 in 100 people globally and is associated with significant quality-of-life burdens, including pain, scarring and comorbidities such as obesity, arthritis, and depression. Diagnosis can take up to 10 years on average, making timely access to effective therapies particularly important.
This latest approval marks the fourth pediatric indication for Cosentyx, reinforcing its established safety profile and expanding its role in the treatment landscape for chronic inflammatory diseases.
NVS has traded between $97.72 and $170.46 over the past year. The stock closed Friday's trading session (March 13, 2026) at $153.44, down 0.53%. During overnight trading, the stock fell further to $153.05, down 0.25%.
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