Eisai Inc., a Japanese pharmaceutical company, has reportedly announced plans to voluntarily remove itself from the market and stop sales of BELVIQ XR CIV and BELVIQ® CIV in United States. This particular action was taken after request from United States FDA, based on the present extensive analysis of data obtained from the CAMELLIA-TIMI 61 trial.
The FDA needed Eisai to perform a long-term trial assessing the effects of cardiovascular linked with the use of drug, during the marketing approval from BELVIQ. The trial of CAMELLIA-TIMI 61 for lorcaserin was a double-blind, randomized, placebo-controlled clinical stage trial to study nearly 12,000 men as well as women over five years with high risk for cardiovascular disease or recognized cardiovascular disease.
The study was performed in eight countries at over 400 sites, which included the U.S., and was the biggest cardiovascular outcome trial performed till date for medication related to weight loss. Lorcaserin, in this trial, enabled prolonged weight loss without a high rate of cardiovascular events than that in placebo.
After reviewing of the data, FDA came to the conclusion that the risks of lorcaserin exceed its benefits. As per FDA there were various numerical imbalance in the frequency of patients with malignancies. The analysis of Eisai of the data from the CAMELLIA-TIMI 61 trial is different from that of FDA. The assessment of the firm was that BELVIQ XR and BELVIQ remain to have a positive profile in the population of patient to which they are designed.
The 2020 Drug Safety Communication by FDA recommends patients to stop taking BELVIQ XR and BELVIQ and to talk to their health care advisor about other weight management programs and weight-loss medications. The Drug Safety Communication of FDA comprises of additional important data for health care providers as well as patients.
Based on the vast lorcaserin clinical data, the firm believes that BELVIQ XR and BELVIQ remain to have a positive profile in the patient population for which they are shown.