Novartis has announced that the European Commission has approved secukinumab (Cosentyx®) for the treatment of moderate-to-severe hidradenitis suppurativa (HS) in adults with a history of inadequate responses to systemic HS therapies.
Secukinumab is the first and only human biologic that directly inhibits interleukin-17A.
The approval comes after positive results of Phase 3 trials, SUNSHINE and SUNRISE. These were identical, double-blind, placebo-controlled, randomized studies that took place across 40 different countries. The two studies evaluated both the short-term (16 weeks) and long-term (up to 52 weeks) efficacy, safety, and tolerability of two dose regimens of secukinumab in adults with moderate-to-severe HS.
Over a 52-week period, participants received either 300 mg of subcutaneous secukinumab administered every two weeks, 300 mg of subcutaneous secukinumab administered every four weeks, or a subcutaneous placebo. Efficacy was defined as the achievement of HS clinical response.
Results demonstrated that in both SUNSHINE and SUNRISE, HS clinical response was significantly greater for participants receiving secukinumab compared to placebo.
According to Professor Christos C. Zouboulis, president of the European Hidradenitis Suppurativa Foundation, “With only one currently approved treatment option, I see HS patients with a tremendous need for alternatives that reduce the disabling physical symptoms of HS, improve the emotional burden and help partially avoid invasive surgery, if treating early.” He adds that “This expanded approval offers physicians an additional effective and, for dermatologists, familiar treatment choice that we can feel confident in prescribing for this complex and challenging disease.”
The United States Food and Drug Administration is expected to make regulatory decisions for the drug later in the year.