Vivus shares soared 90% after an FDA advisory panel voted 20 to 2 to recommend approval of its experimental obesity pill Qnexa.The once per day weight-loss therapy combines low doses of stimulant phentermine, a generic weight loss drug, and topiramate, used to treat epilepsy and migraines. In studies it helped patients lose about 10% of their body weight.
The 20 to 2 vote that sent the stock hurdling higher was a surprise as an advisory panel voted 10 to 6 not to recommend it in 2010, raising concerns about the drug’s cardiovascular effects and the potential risk for birth defects in children born to women who take the drug during pregnancy. The FDA subsequently rejected the drug.
Some of those concerns were raised again in the review posted Friday ahead of today’s panel. But committee members were reassured that steps would be taken to minimize those risks and seemed persuaded by obesity specialists who testified that obesity itself causes health problems and that there is a pressing need for treatments, the New York Times reports.
If ultimately approved, Qnexa would be the first prescription weight loss drug to successfully pass through the FDA process in 13 years.
The lingering question will be whether a necessary cardiovascular outcomes trial is done pre or post approval, TheStreet.com’s Adam Feuerstein explained in a liveblog.
Wall Street analysts expect Qnexa could become a blockbuster with more than $1 billion in annual sales. But Forbes’ Matthew Herper offers investors a bit of caution to inspired investors.