FDA Advisory Committee Recommends Approval of AIN457 (Secukinumab) for Psoriasis

The Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the U.S. Food and Drug Administration (FDA) supported the approval of Novartis Pharmaceuticals’ AIN457 (secukinumab)—a selective interleukin-17A (IL-17A) inhibitor indicated for the treatment of plaque psoriasis—in a unanimous vote. The recommendation was based on results from 10 Phase 2 and Phase 3 clinical trials that evaluated the safety and efficacy of secukinumab in nearly 4,000 patients with moderate to severe psoriasis.

In the Phase 3 trials, secukinumab met all primary endpoints and key secondary endpoints. It demonstrated significant skin clearance at Week 12, and a majority of the patients maintained results at Week 52 with continued treatment. The incidence of serious adverse events was low and comparable for the secukinumab and placebo; common adverse events reported in the treatment group were nasopharyngitis, headache, diarrhea, itching and upper respiratory infection.

FDA action on the Biologics License Application (BLA) is expected in early 2015.

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