FDA panel unanimously backs Novartis’ secukinumab for moderate-to-severe plaque psoriasis

The Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration yesterday voted unanimously to support the approval of Swiss pharma major Novartis’ (NOVN: VX) secukinumab (AIN457), a selective interleukin-17A (IL-17A) inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

The DODAC based its recommendation on the safety and efficacy outcomes from 10 psoriasis Phase II/III clinical studies which included nearly 4,000 patients with moderate-to-severe plaque psoriasis, the company noted. The seven to nil advisory panel vote was in line with FDA staff briefing papers last week, saying the drug’s benefits outweighed its risks.

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