Eisai to Voluntarily Withdraw BELVIQ®/BELVIQ XR® in the U.S.
WOODCLIFF LAKE, N.J., Feb. 13, 2020 /PRNewswire/ -- 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 tothe 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.
The FDA's February 13, 2020 Drug Safety Communication advises patients to stop taking BELVIQ and BELVIQ XR and talk to their health care professional about alternative weight-loss medications and weight management programs. The FDA's Drug Safety Communication includes additional important information for patients and health care providers. Additionally, patients and health care providers with questions can contact Eisai Medical Information at: firstname.lastname@example.org or 1-888-274-2378.
As part of our human health care mission and with the goal of bringing new options to patients who are obese or overweight with weight-related medical conditions, Eisai made BELVIQ and BELVIQ XR available in the U.S. BELVIQ was approved in June 2012 by the FDA as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related co-morbid condition, and was launched in the United States in June 2013. Prior to and following market approval of BELVIQ, the product has been evaluated in more than 30 clinical trials involving over 22,000 patients over the last 15 years. Based on the extensive lorcaserin clinical data, the Company believes that BELVIQ and BELVIQ XR continue to have a positive benefit-risk profile in the patient population for which they are indicated.
Eisai is having discussions with its global distribution partners regarding this issue.
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SOURCE Eisai Inc.