CHMP Recommends Cosentyx for Moderate to Severe Hidradenitis Suppurativa

Novartis is celebrating a significant step forward, as the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Cosentyx (secukinumab) for adults with active moderate to severe hidradenitis suppurativa (HS). This recommendation could pave the way for a new treatment option in Europe for the debilitating skin condition.

Professor Christos C. Zouboulis, President of the European Hidradenitis Suppurativa Foundation, expressed optimism about the potential of Cosentyx, noting the urgent need for more treatment options that can address the multiple symptoms of HS, including boil-like abscesses, pain, and scarring. Dr. Barry McGrath, Acting CEO of HS Ireland, also emphasized the need for new treatments, as HS can significantly impact patients' daily lives, relationships, mental health, and financial well-being.

HS affects 1 in 100 people worldwide, with approximately 200,000 Europeans currently living with moderate to severe stages of the condition. Presently, there is only one approved biologic treatment for HS, which around 50% of patients can lose response to.

The positive CHMP opinion for Cosentyx is based on promising results from two Phase III trials, SUNSHINE and SUNRISE, which demonstrated improved treatment response rates and a meaningful reduction in HS-related pain. The safety findings were consistent with Cosentyx's known safety profile in its approved dermatologic and rheumatologic diseases.

Marie-France Tschudin, President of Novartis Innovative Medicines International and Chief Commercial Officer, stated that the CHMP opinion brings the company closer to offering the first new HS treatment in nearly a decade. If approved, Cosentyx could provide a much-needed alternative for the approximately 200,000 people with moderate to severe HS in Europe.

The recommendation for Cosentyx in HS will now be referred to the European Commission, with a final decision expected within two months. Additionally, the Phase III results from the SUNSHINE and SUNRISE trials have been submitted to the US Food and Drug Administration, with a decision anticipated later this year.