Novartis gets positive CHMP opinion for Cosentyx in adults with hidradenitis suppurativa

HS affects 1 in 100 people worldwide, and in Europe, there are around 200,000 people currently living with moderate to severe stages of the condition. The impact of disease is substantial, even for those on treatment, as there is currently only one approved biologic treatment for HS, and around 50% of patients can lose response. HS causes boil-like abscesses that can burst and become open wounds that can result in irreversible scarring, often in the most intimate parts of the body. Patients describe their HS-related pain as the most debilitating symptom, which worsens as disease severity increases.

The positive CHMP opinion is based on robust results from two trials in the largest Phase III program in HS, SUNSHINE and SUNRISE. The data showed that treatment response rates in patients randomized to Cosentyx continued to improve beyond the primary endpoint analysis at Week 16 to more than 55% of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 52. Additionally, approximately 50% of patients randomized to Cosentyx had a meaningful reduction in HS-related pain at Week 52. Safety findings were consistent with the known safety profile of Cosentyx in its approved dermatologic and rheumatologic diseases and are further supported by data from 8 years of real-world use. The full results were recently published in The Lancet.

“This positive CHMP opinion brings us one step closer to offering the first new HS treatment in nearly a decade,” said Marie-France Tschudin, President of Novartis Innovative Medicines International and Chief Commercial Officer. “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 for Cosentyx in HS will be referred to the European Commission, which is expected to deliver a final decision within 2 months. The Phase III results from SUNSHINE and SUNRISE have also been submitted to the US Food and Drug Administration with a decision expected later this year," the company stated.

Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation of psoriatic arthritis (PsA), moderate to severe plaque psoriasis, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).