Eisai has applied to voluntarily withdraw lorcaserin hydrochloride (Belviq) in both its original and extended release forms.
Following a request from the FDA, Eisai has applied to voluntarily withdraw lorcaserin hydrochloride (Belviq) in both its original and extended-release forms. The FDA concluded that the data from a long-term trial showed the potential risks of the drug outweighed the benefits.
Lorcaserin hydrochloride was approved by the FDA in June 2012 as an adjunct to a reduced-calorie diet and increased physical activity for adult patients with an initial body mass index of 30 kg/m2 or greater. It was launched in the United States in June 2013.
When the weight loss drug received marketing approval from the FDA, the administration also required Eisai to conduct a long-term trial evaluating the cardiovascular effects associated with it. The CAMELLIA-TIMI 61 trial was a randomized, double-blind, placebo-controlled clinical trial that studied approximately 12,000 patients over 5 years. The patients either had established cardiovascular disease or were at high risk for developing cardiovascular disease.
The trial found that patients receiving lorcaserin experienced sustained weight loss without a having a higher rate of major cardiovascular events than patients receiving the placebo.
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When the FDA reviewed the trial’s data, however, experts concluded that the potential risks outweighed the benefits, based on a numerical imbalance in the amount of patients with malignancies. Specifically, during the course of the trial, 462 (7.7%) of the patients treated with lorcaserin were diagnosed with cancers, as opposed to 423 (7.1%) of patients treated with the placebo.
In a statement, representatives of Eisai said they interpreted the data differently. According to the statement, Eisai believes that the drug and its extended-release version have positive benefit-risk profiles, but added that they respect the FDA’s decision and are working on the withdrawal process.
Patients taking lorcaserin hydrochloride are advised to stop taking the drug and talk to their health care provider about alternative options. The statement added that Eisai is discussing the issue with its global distribution partners.
Eisai to Voluntarily Withdraw BELVIQ/BELVIQ XR in the US [news release]. PR Newswire; February 13, 2020. https://prnmedia.prnewswire.com/news-releases/eisai-to-voluntarily-withdraw-belviqbelviq-xr-in-the-us-301004885.html. Accessed February 14, 2020.