Novartis Cosentyx gets European Commission nod for use in adults with hidradenitis suppurativa

“With only one currently approved treatment option, I see HS patients with a tremendous need for alternatives that reduce the disabling physical symptoms of HS, improve the emotional burden and help partially avoid invasive surgery, if treating early,” said Professor Christos C. Zouboulis, President of the European Hidradenitis Suppurativa Foundation, Director of the Departments of Dermatology, Venereology, Allergology and Immunology, Städtisches Klinikum Dessau, and Founding Professor of Dermatology and Venereology at the Brandenburg Medical School, Germany. “This expanded approval offers physicians an additional effective and, for dermatologists, familiar treatment choice that we can feel confident in prescribing for this complex and challenging disease.”

“Since its first approval in 2015, Cosentyx has been used to treat more than 1 million people worldwide. We are pleased to bring Cosentyx as a much needed and trusted treatment option that brings rapid and sustained symptom relief to HS patients,” said Haseeb Ahmad, President Europe, Novartis. “With established market access and patient support programs, Novartis is in a strong position to support fast and widespread access to Cosentyx. This milestone approval is a major step forward in our ambition to deliver quality medicines that alleviate major unmet medical needs.”

A regulatory decision from the US Food and Drug Administration is expected later this year.

Cosentyx is the 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). Cosentyx is a proven medicine and has been studied clinically for more than 14 years. The medicine is backed by robust evidence, including 5 years of clinical data in adults supporting long-term safety and efficacy across moderate to severe plaque psoriasis, PsA and AS. These data strengthen the position of Cosentyx as a treatment across AS, nr-axSpA, PsA, moderate to severe plaque psoriasis (adult and pediatric) and two subtypes of juvenile idiopathic arthritis (JIA), enthesitis-related arthritis and juvenile psoriatic arthritis. More than 1 million patients have been treated with Cosentyx worldwide since its launch in 2015. Cosentyx is approved in more than 100 countries, most recently gaining approval for JIA in the US and Europe.