Lorcaserin - Time Schedule

Time Schedule

Lorcaserin had a Prescription Drug User Fee Act (PDUFA) date of 22 October 2010. On 16 September 2010, a federal advisory committee voted against recommending approval for lorcaserin. In their 9-5 vote, the committee had raised concerns about the safety of the drug, particularly the findings of tumors in rats.

On 23 October 2010, the FDA decided not to approve the drug based on the available data. This was not only because of cancer promoting properties could not be ruled out, but also because the weight loss efficacy was "marginal".

After additional studies were completed and additional information submitted to the FDA, an advisory panel was convened on 10 May 2012. The advisory panel voted 19-4-1 to recommend lorcaserin to the FDA. The FDA stated the weight loss passed FDA standards for efficacy and the drug did not have cancer risks based on clarifications in the data. The FDA panelist recommended that post marketing studies regarding potential heart valve issues be completed. The FDA has not stated one way or the other if they believe this is necessary at this time although no safety markers related have been indicated during clinical studies. On 27 June 2012, the FDA officially approved lorcaserin for use in the treatment of obesity for some adults.