The first and only fully human biologic that directly inhibits interleukin-17A has been granted a positive opinion by the Committee for Medicinal Products for Human Use (CHMP).
[the CHMP’s recommendation of Cosentyx] brings us one step closer to offering the first new hidradenitis suppurativa (HS) treatment in nearly a decade”
The Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for biologic Cosentyx® (secukinumab).
The recommendation for a marketing authorisation “brings us one step closer to offering the first new hidradenitis suppurativa (HS) treatment in nearly a decade,” commented Marie-France Tschudin, President of Novartis Innovative Medicines International and Chief Commercial Officer.
What warranted the CHMP’s decision was Phase III trial data showing Cosentyx provided rapid symptom relief from as early as Week 4, with response rates continuing to improve up to one year.
An interleukin-17A-inhibiting biologic
Cosentyx is the first and only fully human biologic therapy that directly inhibits interleukin-17A and is now recommended for active moderate to severe HS. Already approved in more than 100 countries, Cosentyx has helped to treat over one million patients.
The committee’s positive opinion means “we may soon have a new option to offer our patients in Europe,” noted 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.
Clinical trial data for Cosentyx
The study data is based on two trials in the largest Phase III programme in HS: SUNSHINE and SUNRISE. Treatment response rates in patients randomised to Cosentyx continued to improve beyond the primary endpoint analysis at Week 16 to more than 55 percent of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 521. The full results were recently published in The Lancet.
“If approved, [biologic] Cosentyx will provide a much-needed alternative to support the underserved community of approximately 200,000 people with moderate to severe HS in Europe,” Tschudin explained.
A final decision from the European Commission (EC) is expected to be delivered within two months. The Phase III results from SUNSHINE and SUNRISE have also been submitted to the US Food and Drug Administration (FDA). A regulatory decision is expected later this year.
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