Novartis announced that Cosentyx (secukinumab) has received approval from US Food and Drug Administration (FDA) for treating paediatric patients aged 12 years and older with moderate-to-severe Hidradenitis Suppurativa (HS), making it the only IL-17A inhibitor for this population. The approval of a distinct biologic option for paediatric patients living with HS allows treatment to be tailored to the individual and establishes Cosentyx as a meaningful addition to the treatment landscape.

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

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

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

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 weight. The use of Cosentyx in patients aged 12+ years 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 paediatric clinical trial data from other approved indications. The approval is also supported by dosing analysis, which predicted that weight-based dosing of Cosentyx in paediatric patients can provide similar exposure to adult HS patients.

“With more than a decade of real-world experience across multiple autoimmune diseases, Cosentyx is a well-established treatment option that many physicians trust. 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,” Victor Bultó, President, Novartis US.