"We assess that Belviq and Belviq XR continue to have a positive benefit-risk profile in the patient population for which they are indicated."īased on the change in FDA's risk-benefit assessment and as requested by the agency, however, Eisai said it has agreed to withdraw the products from the U.S.
#CAMELLIA TIMI 61 TRIAL#
"Eisai's interpretation of the data from the CAMELLIA-TIMI 61 trial differs from that of the FDA," the company said in a statement. market, said that it did not agree with the FDA's interpretation of the clinical trial. In its official report, the FDA also asked patients to stop using the medication Belviq and Belviq XR and talk to their health care professionals about other treatment options for weight loss.Įisai, while deciding to withdraw the drug from the U.S. "The trial was conducted in 12,000 patients over five years, and a range of cancer types was reported, with several different types of cancers occurring more frequently in the lorcaserin group, including pancreatic, colorectal, and lung," the agency added. agency, the study revealed that more patients taking lorcaserin were diagnosed with cancer compared to those taking a placebo. When FDA approved lorcaserin in 2012, the agency required the drug manufacturer to conduct a randomized, double-blind, placebo-controlled clinical trial, also known as CAMELLIA-TIMI 61, to evaluate the risk of cardiovascular problems, the agency added.Īccording to the U.S. "In January 2020, we announced we were reviewing clinical trial data and alerted the public about a possible risk of cancer associated with lorcaserin based on preliminary analysis of the data." "We are taking this action because we believe that the risks of lorcaserin outweigh its benefits based on our completed review of results from a randomized clinical trial assessing safety," the FDA said. Food and Drug Administration requested the company to take Belviq and Belviq XR off the market on Thursday. market after reports showed an increase in the incidence of cancer in users. Eisai Pharmaceutical, a Japan-based multinational drug firm, has decided to withdraw its antiobesity drug Belviq (Ingredient: lorcaserin) from the U.S.
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