The Food and Drug Administration has asked Tokyo-based Eisai (OTC: ESALF) to withdraw its weight-loss drugs Belviq and the extended release formulation, Belviq XR, from the U.S. market. The Japanese drugmaker reluctantly complied, submitting a request to voluntarily withdraw the drug.
When the drug was approved in 2012, the FDA required Eisai and its partner Arena Pharmaceuticals (NASDAQ: ARNA) to run a clinical trial to test for the risk of cardiovascular problems. It turns out the study found that patients taking Belviq had a higher incidence of cancer (including pancreatic, colorectal, and lung cancer) than those who received placebo.
The difference wasn't that great: 7.7% for patients taking Belviq compared with 7.1% for those taking placebo. Eisai thinks the weight-loss benefit outweighs the potential increase in cancer risk, but the pharmaceutical company decided not to put up a fight (presumably for fear of repercussions from the agency on other approvals) and will withdraw the drug.