The US Food and Drug Administration (FDA) has requested that Eisai voluntarily withdraw its weight management drug Belviq (lorcaserin) from the US market. Eisai has “submitted a request to voluntarily withdraw” its drug from the country.
This follows a January review of safety clinical trial data, which showed that Belviq was associated with a possible increased risk of cancer in patients.
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In a drug safety release, the FDA stated: “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.”
Belviq was approved in 2012 by the FDA for as an adjunct to lifestyle changes, such as a reduced calorie diet and increased physical activity, for chronic weight management in adults with a body mass index of 30 kg/m2 or greater, or 27kg/m2 or greater with at least one weight-related comorbidity, such as type 2 diabetes,.
An extended release version of Belviq, known as Belviq XR, was approved in 2016 for the same indication. Both formulations are involved in the FDA’s request for a voluntary withdrawal.
When the drug was initially approved in 2012, the FDA required Eisai to conduct a randomised, double-blind, placebo-controlled clinical trial to evaluate the risk of heart related problems, however, in the cardiovascular (CV) outcomes trial CAMELLIA-TIMI61, “which was conducted in approximately 12,000 participants over five years, more patients taking lorcaserin were diagnosed with cancer, compared to patients taking placebo.”
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By GlobalDataThe results found that 462 of the lorcaserin group, which represents 7.7%, were diagnosed with cancer, compared to 423 or 7.1% of the placebo group. A range of cancers were reported, the FDA explains, but those that occurred more frequently in the lorcaserin trial arm were pancreatic, colorectal and lung cancer.
However, in the CAMELLIA-TIMI61 study, Belviq met its primary safety objective that the drug did not cause an increased incidence of major adverse CV events. Eisai’s drug also caused significant improvements in a number of secondary endpoints, include blood pressure, blood glucose, and renal function. These CV results were published by Eisai in July 2018.
As a result of this voluntary withdrawal request, the FDA recommends that patients should stop taking lorcaserin and discuss alternative weight loss medicines and programmes with their healthcare professional.
