Orexigen Gets Review Date For Obesity Drug Candidate Contrave

We now have the final FDA review deadline date for all three of the biggest contestants in the obesity drug race. Today Orexigen Therapeutics announced that FDA has assigned a January 31, 2011 Prescription Drug User Fee Act (PDUFA) date for the firm’s obesity drug candidate, Contrave. This is right about when people expected the date would be, given that Orexigen filed for the drug's approval back in April. The PDUFA date is the goal date for FDA to finish reviewing the company’s new-drug application. This is when folks will be watching for approval decisions. Orexigen's two biggest competitors are Arena's lorcaserin and Vivus's Qnexa. Both of the other drugs' FDA review deadlines are in October of this year. But as we've written before, if you're first to the finish line, you don't have the opportunity to learn from what came before. This is the part where I say "let's not get carried away, here": Anywhere from zero to all three of these experimental drugs could be approved by FDA. It's all about the balance between efficacy and safety. And none of the three companies developing the drug candidates has found a bigger company to partner with them on the project. Though the big companies might be waiting for a bit more clarity on the drugs' approvability, as Leerink Swann analyst Steve Yoo said in a note to investors last March. More reading on Orexigen here.

Author: Carmen Drahl

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