Vivus Inc. (VVUS) said it has responded to the U.S. Food and Drug Administration's concerns about obesity drug Qnexa and has set a meeting for late January to discuss the company's latest effort to win its approval.
The disclosure follows an FDA panel's positive recommendation last week of Orexigen Therapeutics Inc.'s (OREX) weight-loss drug Contrave.
The FDA doesn't have to follow the panel's recommendation, but the positive vote puts Orexigen ahead of Vivus and Arena Pharmaceuticals Inc. (ARNA)--which received negative recommendations from similar panels earlier this year--by easing investor concerns that major clinical studies would be needed before approval.
The FDA in October issued a "complete response letter" for Qnexa saying it couldn't approve the drug application in its current form. The agency asked the company for a comprehensive assessment of Qnexa's potential to cause birth defects and for Vivus to provide evidence that the product doesn't increase the risk for major adverse cardiovascular events.
The company said the FDA didn't request a new clinical trial, but asked for two-year study results involving Qnexa to be submitted.
"Submission of our briefing document and confirmation of our meeting with the FDA indicate the continued progress Vivus is making in seeking U.S. approval of Qnexa for the treatment of obesity," Chief Executive Leland Wilson said Tuesday. "We are confident in the data analyses we have compiled in the briefing document, and we look forward to our meeting with the FDA."
Vivus shares closed Monday at $9.42 and were inactive premarket. The stock is up 45% this month amid the positive news on Orexigen's Contrave.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com