Novartis has announced 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-tumour 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 programme 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 FDA.
In these trials, secukinumab consistently demonstrated very high skin clearance, including superiority to Enbrel (etanercept) in the head-to-head FIXTURE study. Seventy percent or more secukinumab 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 studies; this was maintained in the majority of patients up to Week 52 (with continued treatment). Secukinumab patients in the FIXTURE, ERASURE, FEATURE and JUNCTURE studies (reviewed by the US FDA) also observed significant differences as early as Week 2 and on average, secukinumab 300 mg patients had symptoms reduced by 50% by Week 3, compared to Week 7 for Enbrel (etanercept) patients, in FIXTURE. Secukinumab demonstrated a favorable safety profile, with similar incidence and severity of adverse events between secukinumab treatment arms (300 mg and 150 mg).
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.
