FDA Committee Recommends Novartis Psoriasis Drug Approval

The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee has recommended the approval of Novartis’ first-in-class secukinumab therapy for moderate-to-severe plaque psoriasis.

"Moderate-to-severe psoriasis is a serious condition where patients suffer from skin lesions that cause itching, pain, and scaling. There is a need for novel therapies, as not all treatments are appropriate or effective in every patient,” said Vas Narasimhan, global head of development for Novartis, in a statement. “Today's recommendation…brings us one step closer to delivering an innovative, new treatment option for people suffering from moderate-to-severe psoriasis. We look forward to working with the FDA as it finalizes its review."

Novartis submitted a Biologics License Application for secukinumab in October 2013, and the FDA is expected to act upon it in early 2015.

The regulatory committee’s recommendation for the drug’s approval followed the completion of a phase 3 clinical program involving 4 placebo-controlled studies that examined the efficacy and safety of secukinumab 150 mg and 300 mg in patients with moderate-to-severe plaque psoriasis. In those pivotal studies, the drug met its primary and secondary endpoints of showing significant skin clearance while exhibiting no major safety issues.

Secukinumab is the first selective interleukin-17A (IL-17A) inhibitor to be considered by the FDA for the treatment of moderate-to-severe plaque psoriasis in adult patients. IL-17A is a protein involved in the development of psoriasis.

The FDA committee based its recommendation on the results of 10 phase 2 and phase 3 clinical studies that included nearly 4000 psoriasis patients.