Novartis' Secukinumab Receives Favorable FDA Panel Vote

Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and finally, a response from the regulatory agency regarding the approval status.

Earlier this week, Novartis AG (NVS) announced that the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee (:DODAC) has unanimously voted in favor of approving AIN457 (secukinumab), a selective interleukin-17A (IL-17A) inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients suitable for systemic therapy or phototherapy. The DODAC’s recommendation was based on safety and efficacy data from ten phase II/III studies in patients suffering from moderate-to-severe plaque psoriasis.

A response from the FDA regarding secukinumab’s approval status should be out in early 2015. Novartis has also filed for the approval of secukinumab in the EU where a response should be out by the end of 2014 or early 2015.

Novartis said that secukinumab is the first IL-17A inhibitor to be reviewed by the FDA for this indication.

According to the press release issued by Novartis, psoriasis is a chronic immune-mediated disease that affects 7.5 million Americans and more than 125 million people across the world. Additionally, an analysis of surveys conducted between 2003 and 2011 by the National Psoriasis Foundation showed that 52% of patients suffering from mild, moderate and severe psoriasis were not satisfied with their treatment. Moreover, some of these patients were under-treated or untreated.

Our Take

Although the FDA is not bound to follow the decision of its advisory panels, it generally does so. With the committee voting unanimously in favor of approving secukinumab, we believe chances of gaining approval are high. If approved, secukinumab will be the first IL-17 blocker to be available in the market offering a new treatment option for moderate-to-severe plaque psoriasis. Given the high rate of dissatisfaction among patients regarding existing treatment options in this indication, we believe secukinumab might gain share rapidly.

Currently, Amgen (AMGN) and AstraZeneca (AZN) are developing brodalumab for the treatment of moderate-to-severe plaque psoriasis.

Investors interested in the health care sector may consider Medivation, Inc. (MDVN).

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