Eisai Inc. announced that it will voluntarily withdraw from the market and discontinue sales of BELVIQ® (lorcaserin HCl) CIV and BELVIQ XR (lorcaserin HCl) CIV in the U.S. This action is being taken after a request from the U.S. Food and Drug Administration (FDA), based on the Agency’s recently completed analysis of data from the CAMELLIA-TIMI 61 trial.
At the time of marketing approval from BELVIQ, 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 U.S. 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, FDA concluded that the potential risks of lorcaserin outweigh its benefits. More specifically FDA noted there was a numerical imbalance in the number of patients with malignancies. FDA’s analysis of the study found that during the course of the trial, 462 (7.7 percent) patients treated with lorcaserin were diagnosed with cancers compared to the placebo group, in which 423 (7.1 percent) patients were diagnosed with cancers.
Eisai’s interpretation of the data from the CAMELLIA-TIMI 61 trial differs from that of the FDA. The Company’s assessment is that BELVIQ and BELVIQ XR continue to have a positive benefit-risk profile in the patient population for which they are indicated. However, based on the change in FDA’s risk-benefit assessment and as requested by the Agency, Eisai has agreed to voluntarily withdraw the products from the U.S. market. Eisai respects the FDA’s decision and is working closely with the Agency on the withdrawal process.