The Japanese drugmaker Eisai on Thursday announced plans to voluntarily withdraw its weight-loss drug Belviq from the U.S. market after FDA raised concerns about the drug's link to increased cancer risk.
The drug, which was originally developed by San Diego-based Arena Pharmaceuticals, received U.S. approval in 2012. FDA approved the drug for adults with a body mass index (BMI) of 30 and adults with a BMI of 27 who have heart risks such as high blood pressure, high cholesterol, or Type 2 diabetes.
The evidence available at the time showed almost 50% of patients who took Belviq, which costs $300 per month without insurance, lost at least 5% of their weight over a year and almost 25% of patients lost at least 10% of their weight over a year. Those results were twice as better as those of patients in the placebo group, the Associated Press reports. However, an animal safety study also tied Belviq to an increased occurrence of tumors in rats.
Since the drug's approval, sales of the treatment have been low, which prompted Arena to sell the drug to Eisai. Eisai recorded $41 million in U.S. sales of the drug in the first nine months of 2019.
FDA asks Eisai to pull weight-loss drug from the US market
Last week, FDA asked Eisai to pull Belviq from the U.S. market after more conclusive evidence linked Belviq to a higher incidence of cancer in people.
FDA said the new evidence is from a clinical trial that began after the agency approved the drug to evaluate the drug's long-term heart safety.
Though the trial's data did not show an increased risk of heart-safety problems, FDA found a number of patients taking Belviq developed cancer. According to the trial's data, 462 patients using Belviq—or 7.7%—were diagnosed with 520 primary cancers, including colorectal, lung, pancreatic. In comparison, 423 patients in the placebo group who were not using Belviq—or 7.1%—received a cancer diagnosis. FDA noted the increase in cancer risk only appeared with prolonged use of Belviq.
Eisai said it disagreed with FDA's interpretation of the findings and thinks the drug's benefits outweigh the risks, but agreed to voluntarily withdraw Belviq and an extended-release version of the drug, called Belviq XR, from the U.S. market.
FDA recommended patients stop using Belviq immediately, discard any leftover pills, and contact their providers for advice on alternative treatments. However, FDA said patients who took Belviq do not have to undergo any special screenings.
FDA said, "We are taking this action because we believe that the risks of [Belviq] outweigh its benefits based on our completed review of results from a randomized clinical trial assessing safety" (Feuerstein, STAT News, 2/13; Johnson, AP/Washington Post, 2/13; Owens, "Vitals," Axios, 2/13).