The Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the FDA voted 7 to 0 to support the approval of AIN457 (secukinumab), 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 (a drug that is absorbed into the bloodstream and distributed to all parts of the body) or phototherapy (light therapy). 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.

"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 Development, Novartis Pharmaceuticals. "Today's recommendation is based on the efficacy and safety data put forth in our robust clinical trial program and 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."

The Phase III clinical program for secukinumab included four placebo-controlled pivotal studies which examined secukinumab 300 mg and 150 mg in patients with moderate-to-severe plaque psoriasis. In these studies, secukinumab met all primary and key secondary endpoints, including Psoriasis Area and Severity Index (PASI) 75 and 90 and Investigator's Global Assessment modified 2011 (IGA mod 2011) 0/1 responses, showing significant skin clearance at Week 12. In addition, a majority of secukinumab-treated patients who achieved PASI 75 response and IGA mod 2011 0/1 at Week 12 maintained the response at Week 52 with continued treatment.

Currently available data showed no major safety issues.  In the pooled analysis of the placebo-controlled period of the pivotal Phase III studies, the incidence of serious adverse events (SAEs) was low and comparable for both doses of secukinumab and placebo (2.0 percent for both 300 mg and 150 mg vs. 1.7 percent for placebo). Commonly reported adverse events (AEs) observed with secukinumab were nasopharyngitis, headache, diarrhea, pruritus (itching), and upper respiratory infection.

Novartis submitted a Biologics License Application (BLA) 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.

"The effects of psoriasis go well beyond the visible impact on the skin and frequently have a negative impact on many aspects of a person's daily life," said Dr. Mark G. Lebwohl, Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai and an investigator in the secukinumab clinical trial program. "Today's recommendation offers the promise of a potential treatment for appropriate patients living with psoriasis, who are eager for new options to help them manage their disease."