FDA Panel to Review Vivus Anti-Obesity Drug

The Wall Street Journal

 

Vivus Inc. said a Food and Drug Administration advisory committee is tentatively set to review the company's new-drug application for its experimental Qnexa obesity treatment.

Chief Executive Leland Wilson said the July 15 review will mark a critical milestone for Qnexa and the company.

Vivus is one of three drug developers hoping to get regulatory approval of new oral obesity treatments, along with Orexigen Therapeutics Inc. and Arena Pharmaceuticals Inc. Vivus earlier this year also said that Qnexa was shown to reduce sleep apnea, when breathing stops briefly during sleep, by 69% in a midstage trial.

While the sleep-apnea data were preliminary and based on a small set of patients, the results could help Qnexa eventually become the first drug for the condition, currently treated only by devices, and may further bolster Vivus's resume in its search for a large pharmaceutical company partner for the antiobesity drug. Vivus would need FDA approval to market a drug for that use.

Qnexa is a combination of weight-loss drug phentermine and controlled release topiramate, sold as Topamax by Johnson & Johnson.

Vivus Requests FDA Approval For Obesity Drug

LA Times

Drugmaker Vivus Inc. said Tuesday it asked regulators to approve its drug candidate Qnexa as a treatment for obesity.

Vivus said it has filed a new drug application with the Food and Drug Administration. A week ago, competitor Arena Pharmaceuticals Inc. said it filed for approval of its own experimental obesity drug, lorcaserin. Orexigen Therapeutics plans to request marketing approval for its product Contrave32 in the first half of 2010.

Vivus reported positive results from two late-stage clinical trials of Qnexa in September. Qnexa, lorcaserin and Contrave32 could all reach the market around the same time, and some analysts say they believe Qnexa could be the top seller of the group based on the weight loss observed in clinical testing.

In morning trading, Vivus shares rose 17 cents to $9.84.