A Food and Drug Administration panel voted today in favor of approval for Orexigen Therapeutics’ (NASDAQ:OREX) drug Contrave for obesity. The drug has a PFUDA action date of January 31, 2011, although a decision could come before then. The FDA typically follows panel guidance, but is not bound to follow its decision.
The FDA panel voted 13-7 in favor of Contrave, saying that the drug’s benefits outweighed its risks. The panel raised concerned about increased blood pressure and pulse, which could possibly cause heart attacks, and voted 11-8 in favor of a post-approval study. Interestingly, Contrave’s efficacy is much lower than two other drug candidates for obesity, with one panel member saying he would rather use one of these other drugs as it has “almost twice the efficacy” of Contrave, according to Ramsey Bagdadi.
The panel vote came as a surprise, as earlier this year two other obesity drugs received negative panel votes. Vivus’s Qnexa received a negative vote, while Arena Pharmaceuticals’ lorcaserin received a 9-5 negative vote, with the panel citing conerns about cancer that occurred in rats during testing, an issue that had not been addressed publicly by the company before. Both drugs subsequently received Complete Response Letters from the FDA.
Orexigen stock was up an astounding 160% in after hours trading to $12.42.
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