FDA Advisory Committee Unanimously Recommends Approval of Novartis' AIN457 for Patients with Moderate-to-Severe Plaque Psoriasis

Novartis has announced the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the FDA has voted unanimously 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 4000 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 finalises its review."

The Phase III clinical programme 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. PASI measures the redness, scaling and thickness of psoriatic plaques, and the extent of involvement in each region of the body. Treatment efficacy is assessed by the reduction of the score from baseline (i.e., a 75% reduction is known as PASI 75 and a 90% reduction is known as PASI 90). PASI 90 is a higher standard of skin clearance compared to PASI 75.

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% for both 300 mg and 150 mg vs. 1.7% 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. In addition, submissions have been made with regulatory authorities in the EU with an expected decision anticipated in late 2014 or early 2015.