European Medicines Agency recommends Cosentyx for adults with hidradenitis suppurativa

Key takeaways:

• Based on the recommendation, the European Commission will make a final decision within 2 months.
• If approved, Cosentyx will be the first new treatment for this indication in nearly a decade.

The European Medicines Agency has issued a positive opinion of Cosentyx for the treatment of adults with moderate to severe hidradenitis suppurativa and recommends a marketing authorization be granted, Novartis announced in a release.

The recommendation of Cosentyx (secukinumab) for the treatment of hidradenitis suppurative (HS) in adults is from the agency’s Committee for Medicinal Products for Human Use (CHMP).

Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A, a cytokine in many inflammatory skin conditions. It is currently approved in more than 100 countries, having gained recent approval for juvenile idiopathic arthritis in the United States and Europe.

“This positive CHMP opinion brings us one step closer to offering the first new HS treatment in nearly a decade,” Marie-France Tschudin, MBA, president of Novartis Innovative Medicines International and chief commercial officer, said in the release. “If approved, Cosentyx will provide a much-needed alternative to support the underserved community of approximately 200,000 people with moderate to severe HS in Europe, many of whom are living with painful, uncontrolled symptoms.”

The recommendation was based on data from two phase 3 trials, SUNSHINE and SUNRISE, in which patients with HS were randomly assigned to receive a 300 mg dose of Cosentyx every 2 or 4 weeks or placebo. The study’s initial 16 weeks was followed by an extension period of up to 52 weeks.

In the treatment group, a significantly greater proportion of patients (> 50%) receiving Cosentyx achieved a Hidradenitis Suppurativa Clinical Response at week 52.

According to the release, approximately 50% of patients on the study drug also experienced a significant reduction in pain by week 52.

Based on the recommendation, the European Commission will make a final decision within 2 months. Later this year, a decision is also expected to be released by the FDA regarding the submission of the program’s phase 3 results in 2022.