FDA Advisory Panel Recommends Lorcaserin
Posted: June 1, 2012
The FDA advisory panel voted 18-4 to advocate the diet pill Lorcaserin (which uses the trade name Lorqess) for FDA approval. This is not the first time Lorcaserin has been before the FDA advisory panel. In 2010, the committee voted against recommending approval for Lorcaserin, citing an assortment of concerns, including a less-than-impressive weight loss and data from animal studies suggesting that Lorqess increased the risk of tumors in rodents. The FDA rejected Arena’s application shortly after, asking for more safety data.
In February, an FDA advisory committee voted overpoweringly in favor of the Qnexa diet pill developed by Vivus. Of course, the recommendations are not a promise the FDA will issue approvals. But after both diet pills received a large majority of support from the FDA panels it would suggest that the safety concerns that weighed down the drug makers during earlier panel meetings have been adequately addressed and that at the FDA will approve the pills.
There are still concerns over the dangers involving valvulopathy, which is heart valve damage, and cardiovascular adverse events. Some committee members discussing the likelihood of requiring echocardiograms before patients are prescribed Lorqess, given that an increased risk CV event could not be ruled out.
A related question is whether the FDA would require a REMS, or Risk Evaluation and Mitigation Strategy. A REMS was proposed for Vivus pill, but a key issue with that drug is the risk of birth defects, which does not plague the Arena pill. Nonetheless, the FDA has been consistently cautious in viewing diet pills because these drugs are likely to be widely and, perhaps, inappropriately used, suggesting REMS programs are likely to be employed.
An FDA advisory committee recommended in March 2012 that companies that make obesity drugs should rule out excessive cardiovascular risk prior to drug approval. Lorqess was developed prior to that meeting, so its clinical trials weren’t designed to capture cardiovascular risk. And panelists seemed to forgive Arena for not having adequate cardiovascular data given that the FDA “moved the goal posts” on obesity trials midway through.
With obesity at epidemic proportions more and more prescription diet pills will start flooding the market and the FDA will start approving them. The question will become how much safety they will be willing to sacrifice to achieve these goals.