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Eisai disagrees with FDA decision.
Eisai Inc. is stopping sales of its weight loss drug in the US due to FDA concerns over cancer risks.
The manufacturer is voluntarily withdrawing lorcaserin HCI (Belviq and Belviq XR) in the U.S. after FDA found that, in relation to cancer malignancies, the risks of taking the weight loss drug outweighs its benefits.
However, based on “extensive” lorcaserin clinical data, Elsai believes that Belviq and Belviq XR “continue to have a positive benefit-risk profile in the patient population for which they are indicated,” the pharma maker said in a press release.
Eisai is “having discussions with its global distribution partners regarding this issue.”
When it approved Belviq, FDA required Eisai to perform a long-term trial evaluating the cardiovascular effects associated with the use of the drug. The agency recently finished its analysis of Elsai’s CAMELLIA-TIMI 61 clinical trial, which studied around 12,000 men and women over 5 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,” Elsai said.
In the trial, lorcaserin facilitated sustained weight loss without a higher rate of major cardiovascular events, compared to placebo.
However, the FDA noted there was a numerical imbalance in the number of patients with malignancies. FDA’s analysis of the study found that 462 (7.7%) patients treated with lorcaserin were diagnosed with cancers compared to the placebo group, in which 423 (7.1%) patients were diagnosed with cancers.
In its Drug Safety Communication, FDA said that several different types of cancers - including pancreatic, colorectal, and lung cancer - occurred more frequently in the lorcaserin group.
FDA said that patients should stop taking lorcaserin and talk to their health care professionals about alternative weight-loss medicines and weight management programs.
Eisai's interpretation of the data from the clinical trial differs from that of the FDA, the manufacturer said.
“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,” Elsai said.
Before and after market approval of Belviq, the product has been evaluated in more than 30 clinical trials involving more than 22,000 patients over the last 15 years, Elsai added.
Patients and healthcare providers with questions can contact Eisai Medical Information at: firstname.lastname@example.org or 1-888-274-2378.