Novartis announced that Cosentyx (secukinumab) received US Food and Drug Administration approval for treating pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa. The approval makes Cosentyx the only IL-17A inhibitor approved for this patient population, according to a company statement.

Hidradenitis suppurativa is a chronic inflammatory skin disease that causes recurring boil-like lesions, which can rupture into painful wounds and lead to scarring. The condition affects as many as 1 in 100 people worldwide and often begins around puberty. More than half of patients develop symptoms during adolescence.

The approval allows Cosentyx to be used in patients aged 12 and older with moderate to severe hidradenitis suppurativa who weigh 30 kg or more. The treatment uses weight-based dosing tailored to pediatric patients.

The FDA approval is supported by well-controlled adult studies and pharmacokinetic modeling extrapolated from adult hidradenitis suppurativa and psoriasis clinical trials, as well as pediatric clinical trial data from other approved indications. Dosing analysis predicted that weight-based dosing in pediatric patients can provide similar exposure to adult patients with hidradenitis suppurativa.

This marks the fourth pediatric indication for Cosentyx. The drug has been available for more than a decade across multiple autoimmune diseases.

"The approval of Cosentyx represents an important advancement for younger HS patients who have had limited treatment options," said Dr. Alexa Kimball, lead investigator of clinical trials in adult hidradenitis suppurativa patients and Professor of Dermatology at Harvard Medical School.