FDA Panel Backs Novartis' Psoriasis Drug

(RTTNews) - Novartis AG (NVS) said Monday that the Dermatologic and Ophthalmic Drugs Advisory Committee to the US Food and Drug Administration has voted unanimously to support the approval of AIN457, a selective interleukin-17A inhibitor, for the treatment of moderate-to- severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

The recommendation is based 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.

Novartis submitted a Biologics License Application for secukinumab to the FDA in October 2013 and the FDA action date is expected in early 2015. Additionally, submissions have been made with regulatory authorities in the EU with an expected decision anticipated in late 2014 or early 2015.