21 November 2014 - 21 November 2014 - Swiss Novartis (VTX:NOVN) reported Friday that the European Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion recommending approval of the human monoclonal antibody 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.

CHMP's recommendation would mean doctors could use Cosentyx first-line to treat their psoriasis patients, as an alternative to other first-line systemic treatments, which have considerable side effects. To date, all biologic treatments for psoriasis, including anti-tumour necrosis factor therapies (anti-TNFs) and ustekinumab are recommended for second-line systemic therapy in Europe.

According to Novartis, Cosentyx (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. Cosentyx works by inhibiting the action of IL-17A - a protein found in high concentrations in skin affected by the disease.

David Epstein, division head, Novartis Pharmaceuticals, said the positive CHMP opinion for Cosentyx as a first-line treatment of psoriasis brings the company a step closer to approval in Europe and making clear skin a reality for psoriasis patients. Thus the company may change the way psoriasis is treated, as 50% of patients are unhappy with their current psoriasis therapies, showing an urgent need for new treatments that clear skin more quickly and for a longer time, Epstein added.

CHMP based its favourable opinion on the encouraging findings from the Phase III clinical study programme in moderate-to-severe plaque psoriasis. The positive opinion follows the unanimous recommendation of approval in October from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US FDA.

In the Phase III trials, Cosentyx consistently demonstrated very high skin clearance, including superiority to Enbrel ((etanercept), a standard of care anti-TNF medication) in the head-to-head FIXTURE trial. Some 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 in the FIXTURE and ERASURE trials. This was maintained in the majority of patients up to week 52 (with continued treatment). Cosentyx patients in the FIXTURE, ERASURE, FEATURE and JUNCTURE trials, which were reviewed by the US FDA, also observed significant differences as early as week two. On average, Cosentyx 300 mg patients had symptoms reduced by 50% by week three, compared to week seven for Enbrel patients, in the FIXTURE trial. Cosentyx exhibited a favourable safety profile, with similar incidence and severity of side effects between Cosentyx treatment arms (300 mg and 150 mg).