Novartis psoriasis drug gets EC approval

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Novartis has announced that the European Commission (EC) has approved Cosentyx(TM) as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

Novartis’ Cosentyx (secukinumab, formerly known as AIN457), at a dose of 300 mg, is the first and only interleukin-17A (IL-17A) inhibitor to be approved in Europe. This approval marks a significant milestone in the treatment of psoriasis, providing a new and important first-line biologic treatment option for patients.

Cosentyx is the only biologic that can be used as first-line systemic therapy in the treatment of psoriasis and as an alternative to treatments that have significant side effects. Currently, all biologic treatments for psoriasis, including anti-tumour necrosis factor therapies (anti-TNFs) and Stelara® (ustekinumab) are recommended for second-line systemic therapy in Europe.

Achieving clear skin is the ultimate treatment goal for patients with psoriasis. In Phase III studies, 70% or more Cosentyx 300 mg patients achieved clear skin (PASI 100) or almost clear skin (PASI 90) during the first 16 weeks of treatment. Cosentyx showed superiority to Stelara® in the Phase IIIb CLEAR study.

50% of psoriasis patients are not content with current therapies. 

David Epstein, Division Head, Novartis Pharmaceuticals, said: “With this groundbreaking news from the European Commission, clear skin may now be a reality for patients living with psoriasis.

“Nearly half of psoriasis patients are not content with current therapies, including biologic treatments, showing a significant unmet need for patients. Cosentyx, with a first-line systemic indication for treatment of psoriasis will provide patients a better chance of achieving clear or almost clear skin.”