Meanwhile, other investors have rallied around the company, issuing hundreds of complaints to the agency showing their belief that the drug should be approved. One casual group of investors calling itself the Blue Ocean Research Group, garnered a response from the FDA that was made public on Oct. 21, saying that the agency “takes all comments and concerns about advisory committee proceedings seriously” and that the advisory committee forum “allows the committee to make recommendations after taking into account all perspectives.” The FDA response went on to say that it “regrets” not having a toxicologist present at the meeting, but that the research was well vetted by both the Center for Drug Evaluation and Research (CDER) Executive Carcinogenicity Assessment Committee and FDA toxicologists.
While not a surprise, the complete response letter for lorcaserin indicates that the FDA will take a hard line with obesity drugs going forward. Arena’s competitor, Vivus Inc., will be up for an approvable decision for its obesity drug Qnexa on Oct. 28.
Lisa LaMotta is a writer for “The Pink Sheet.” Hospitalist News Digital Network and “The Pink Sheet” are published by Elsevier.