FDA requests Eisai to withdraw Belviq from US market

After a request from the US Food and Drug Administration, based on the agency's recently completed analysis of data from the CAMELLIA-TIMI 61 trial, Japanese drug major Eisai (TYO: 4523) says that it will voluntarily withdraw from the market and discontinue sales of the weight-loss drug Belviq (lorcaserin HCl) CIV and the extended release formulation Belviq XR CIV in the USA.

At the time of marketing approval from Belviq in 2012, the FDA required Eisai to perform a long-term trial evaluating the cardiovascular effects associated with the use of the drug. The CAMELLIA-TIMI 61 trial for lorcaserin was a randomized, double-blind, placebo-controlled clinical trial to study approximately 12,000 men and women over five years with established cardiovascular disease or at high risk for cardiovascular disease. This study was conducted at over 400 sites in eight countries including the USA and is the largest cardiovascular outcome trial conducted to date for a weight loss medication. In this trial, lorcaserin facilitated sustained weight loss without a higher rate of major cardiovascular events than that with placebo.

Following its review of the data, the FDA concluded that the potential risks of lorcaserin outweigh its benefits. More specifically, the FDA noted there was a numerical imbalance in the number of patients with malignancies. The FDA's analysis of the study found that during the course of the trial, 462 (7.7%) patients treated with lorcaserin were diagnosed with cancers compared to the placebo group, in which 423 (7.1%) patients were diagnosed with cancers.