Friday, July 23, 2010

Qnexa FDA Committee Rejection Focuses Attention on Vivus' Survival

So confident was Vivus (VVUS-$5.75) in the efficacy of Qnexa across a range of overweight or obese patients (with or without co-morbid conditions, from diabetes to hypertension), management deferred entering into any clinical and marketing partnership(s) until after the July 15 meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee.

Big Mistake! Although acknowledging an unmet need in obesity treatment - and Qnexa's impressive efficacy, average weight loss was 14.7 percent (37 lbs) - panel members voted 10 - 6 against approval, voicing concerns about Qnexa’s risk of birth defects, increases in adverse psychiatric events, and a dearth of long-term data on cardiovascular outcomes (more than 56 weeks).

What now for Vivus and its anti-obesity drug Qnexa?

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.

1 comment:

Anonymous said...

Hi David,

The link you use here is broken. The article's still on bnet but it looks like the URL is slightly different.