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Novartis updates label for psoriasis drug in EU

The Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Novartis’s Cosentyx (secukinumab), the first interleukin-17A (IL-17A) approved to treat psoriasis.

The company said that the label update includes 52 week data from the CLEAR study demonstrating the long-term superiority of Cosentyx versus Stelara (ustekinumab) in psoriasis. The updated label also includes use of Cosentyx to treat moderate-to-severe scalp psoriasis, which affects approximately 60 million people worldwide.

The updated label for Cosentyx on scalp psoriasis, in a difficult-to-treat area of the body, addresses an important unmet need. Many patients with scalp psoriasis do not achieve an adequate response from currently available treatments. Also, scalp psoriasis can be particularly challenging to treat as disease activity is often maintained through hair care, scratching, and shampooing of the scalp, adding to the fact that the application of topical treatments is challengin.

Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis said, “Cosentyx is an innovative, groundbreaking treatment for people living with auto-inflammatory diseases, and we’re proud to continuously expand treatment possibilities for an even greater number of patients.”

Novartis noted in its press release that Cosentyx is currently the only fully human IL-17A inhibitor to demonstrate efficacy and safety in a dedicated Phase III study of scalp psoriasis.

The label update is applicable to all European Union and European Economic Area countries. Cosentyx is approved in more than 75 countries for the treatment of moderate-to-severe plaque psoriasis. Cosentyx is also approved in more than 70 countries for the treatment of active PsA and AS.

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