FDA Panel Backs Novartis' Secukinumab For Psoriasis

Novartis announced that it has received the full support of the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the U.S. Food and Drug Administration (FDA) for the regulatory approval of its drug secukinumab as treatment for moderate-to-severe plaque psoriasis.

Secukinumab is a first-in-class selective interleukin-17A (IL-17A) inhibitor that works against the release of messenger proteins known as pro-inflammatory cytokines. IL-17A is a type of cytokine implicated in psoriasis through its influence on autoimmune responses. Novartis filed a Biologics License Application (BLA) for secukinumab as treatment of moderate-to-severe plaque psoriasis in adult patients who are eligible for either systemic therapy or phototherapy.

Vas Narasimhan, Global Head Development at Novartis, said, “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 DODAC’s 7-0 vote of approval recommendation in favor of secukinumab was based on positive safety and efficacy outcomes from several Phase 2 and Phase 3 clinical studies in psoriasis involving almost 4,000 patients. The investigational drug is presently under review by the FDA, which is expected to give a decision early next year. Novartis said that it has also filed submissions with regulatory authorities in the EU and anticipates a regulatory decision late this year or early next year.

Eric Schmidt, senior research analyst on biotech stocks at Cowen & Co., said that he expects new injectable drugs, such as secukinumab, to have a gradual take-off but eventually become a profitable multi-billion-dollar market, reports the Wall Street Journal. Indeed, considering the number of people afflicted with psoriasis around the world, and in the U.S. alone, the drug could easily bring in a hefty sum. Psoriasis is a chronic autoimmune disease that affects over 125 million people around the world including 7.5 million patients in the U.S.