Novartis announced 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 population. 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 landscape. HS is a chronic, 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 1 in 100 people worldwide and often begins around puberty. More than half of patients develop symptoms during adolescence, highlighting the importance of early 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 weight.
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 indications. 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 patients.
