Secukinumab gets one step closer to approval in Europe for treating psoriasis.

[Fred]

Following on from other reports recently about Secukinumab showing good results when up against Enbrel, Novartis have announced it has received positive opinion recommending approval from the Committee for Medicinal Products for Human Use (CHMP) for a first line treatment of moderate-to-severe plaque psoriasis in adults.

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Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Cosentyx™ (secukinumab, formerly known as AIN457) as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

This recommendation would mean doctors could use secukinumab first-line to treat their psoriasis patients, as an alternative to other first-line systemic treatments, which have significant side effects. Currently, all biologic treatments for psoriasis, including anti- tumor necrosis factor therapies (anti-TNFs) and ustekinumab are recommended for second-line systemic therapy in Europe.

Secukinumab (at a dose of 300 mg) is the first interleukin-17A (IL-17A) inhibitor to be recommended as a first-line treatment option for psoriasis patients who require systemic therapy in Europe. Secukinumab works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by the disease.

"This positive CHMP opinion for secukinumab as a first-line treatment of psoriasis brings us one step closer to approval in Europe and making clear skin a reality for psoriasis patients," said David Epstein, Division Head, Novartis Pharmaceuticals. "With this exciting news, we may change the way psoriasis is treated, as 50% of patients are unhappy with their current psoriasis therapies, demonstrating an urgent need for new treatments that clear skin faster and for a longer time."

The ultimate aim of psoriasis treatment is clear skin for patients. In clinical studies, 70% or more patients achieved clear skin (PASI 100) or almost clear skin (PASI 90) with secukinumab 300 mg during the first 16 weeks of treatment.

The CHMP opinion was based on the positive results of the Phase III clinical trial program in moderate-to-severe plaque psoriasis and follows the unanimous recommendation of approval in October from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration (FDA).

The European Commission reviews the recommendations of the CHMP. The final decision on approval, usually granted in approximately two months of the CHMP opinion, will be applicable to all European Union (EU) and European Economic Area (EEA) countries.

Source: novartis.com

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