Novartis Cosentyx® gains positive CHMP opinion for hidradenitis suppurativa

pharmafile | April 27, 2023 | News story | Business Services CHMP, Cosentyx, Dermatology, Novartis 

Basel, April 26, 2023 — Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion and recommended granting a marketing authorization for Cosentyx® (secukinumab) in adults with active moderate to severe hidradenitis suppurativa (HS). 


“HS is an under-treated inflammatory skin disease, and I regularly see its devastating impact in my practice. We need more options that can address its multiple signs and symptoms, especially boil-like abscesses, pain and scarring, and bring fast, long-lasting results,” said Professor Christos C. Zouboulis, President of the European Hidradenitis Suppurativa Foundation, Director of the Departments of Dermatology, Venereology, Allergology and Immunology, Staedtisches Klinikum Dessau and Founding Professor of Dermatology and Venereology at the Brandenburg Medical School, Germany. “Today’s news gives me hope that we may soon have a new option to offer our patients in Europe.”


“HS pain can be excruciating at times, limiting my ability to do everyday tasks such as dressing, bathing, walking, exercise, cooking and cleaning. It’s humbling to have to ask others to help tie my shoelaces. Beyond the pain, the drainage, fatigue and other HS symptoms impact my relationships, intimacy, mental health, work and finances. New treatment options are needed to help improve the lives for people with HS,” said Dr. Barry McGrath, PhD, Acting CEO, HS Ireland.


HS affects 1 in 100 people worldwide5, and in Europe, there are around 200,000 people currently living with moderate to severe stages of the condition6. 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 response7. 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 body5,8. Patients describe their HS-related pain as the most debilitating symptom, which worsens as disease severity increases5,8.


The positive CHMP opinion is based on robust results from two trials in the largest Phase III program in HS, SUNSHINE and SUNRISE9,10. 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 521. Additionally, approximately 50% of patients randomized to Cosentyx had a meaningful reduction in HS-related pain at Week 521. 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 use1. The full results were recently published in The Lancet1.


“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.

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