VIVUS, an emerging pharmaceutical company in the Bay Area of California announced that the FDA Endocrinologic and Metabolic Drugs Advisory Committee will review its NDA filing for its lead drug, Qnexa. The review is scheduled for July 15, 2010. The Advisory Committee Briefing Document shoudl appear on the FDA website around July 13, 2010.

VIVUS drug Qnexa to get Panel Review

VIVUS announced in late March that the FDA had scheduled Qnexa for review at a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee on July 15.

The FDA refers about 20 to 25% of NDA submissions for new chemical entities for committee or panel review.  The panel consists of experts in the area of the indication itself or general field around this indication; these experts scrutinize a synopsis of the submitted and related data and render an opinion on the safety and efficacy of the drug.  The FDA does not often follow the advice of this panel.  It sometimes, though infrequently, accepts a drug that the panel rejects; there are more examples of the agency rejecting a drug that the committee votes for approval.

There are currently three drugs submitted for marketing approval.  Qnexa is the only one thus far that has been submitted to a review panel.  The NDA was filed on December 28, 2009 and accepted for review on March 1.  Three weeks later on March 26, the drug was referred to the review committee.  On or about July 13, the FDA should publish an advisory committee briefing document on the website.  Sometimes the reviewer includes his or her opinion about whether the drug should be approved.  It’s likely that the drug was referred to the panel for an assessment on safety rather than efficacy.  VIVUS continues to carry out work to support the safety claims of the drug.  Last Monday, May 5, VIVUS posted a press release about a presentation at the European Congress Focused on Cardiovascular Prevention and Rehabilitation where the a lead investigator, Dr Kishore Gadde of the obesity clinical trials at Duke University presented data supporting the safety of the drug.

VIVUS is in a head-to-head race with Arena Pharmaceuticals, which also submitted an NDA for a weight reduction drug, lorcaserin.  Lorcaserin was issued a PDUFA date of October 22, 2010; so far, the drug has not been referred to an independent panel for review.  Qnexa has a PDUFA date a week later on October 28.  VIVUS showed greater weight reduction with Qnexa, but questions remain about the long-term safety of the drug; the Arena drug, lorcaserin, showed a slightly lower weight loss; however, there are fewer concerns about the safety of this therapy.

The next date to watch is the publication of the Advisory Committee Briefing Document for Qnexa which should appear on the FDA website around July 13.