FDA delays decision on Orexigen’s Contrave by three months – June 11, 2014

This morning, the FDA delayed announcing a decision on Orexigen/Takeda’s anti-obesity drug, Contrave (buproprion/naltrexone) by three months ­– the new PDUFA date is September 11. By coincidence or not, that date is also the FDA advisory committee meeting for lira for obesity. For context, this announcement follows a series of regulatory delays Orexigen has faced in the US. Orexigen originally filed Contrave with the FDA in 2010; however, the FDA rejected the drug in January 2011 demanding a pre-approval cardiovascular outcomes trial to address cardiovascular safety concerns. Orexigen quickly enrolled the CVOT (called the Light Study) and used interim results from the trial to resubmit the agent in December 2013. Initially, the FDA assigned a PDUFA date of June 10, 2014; however, the FDA later modified the date to June 11, indicating that it had miscalculated the review period (this was a bit random). The FDA explained that today’s review extension is necessary to reach agreement on a post-marketing obligation that is related to a previously agreed-upon evaluation of cardiovascular outcomes. In a press release, Orexigen management expressed its appreciation for the FDA’s involvement and its confidence in reaching agreement on this obligation. Indeed, the delay suggests that Contrave will likely be approved so long as an agreement is reached. Unfortunately, this review extension, of course, delays Orexigen and partner Takeda’s launch of Contrave, and the stock market has responded in kind: Orexigen’s shares dropped by 15% following the announcement. As a reminder, if Contrave is approved, it will become the third obesity drug with FDA approval and will be available alongside Vivus’ Qsymia (phentermine/topiramate) and Arena/Eisai’s Belviq (lorcaserin). We are optimistic about Contrave’s chances for commercial success, despite the tougher road Qsymia and Belviq have had; we believe the combination of Takeda’s involvement and the fact that there’s less controversy should make Contrave more attractive for PCPs. Regardless, we think there’s certainly a chance that from a low base, Orexigen success would lift all boats – we have great expectations for September.