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.