Eisai Co. said that it plans to pull its weight-loss drug Belviq off the market in the U.S. after clinical trials demonstrated an increased incidence of cancer in users.
When the drug was approved in 2012, the FDA required a long-term trial studying the drug's cardiovascular impact. The CAMELLIA-TIMI 61 trial studied approximately 12,000 men and women over five years with established cardiovascular disease or at high risk for cardiovascular disease. 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.
As such, Japan-based Eisai is voluntarily withdrawing the drug from the market and discontinuing sales. But this doesn't mean the drugmaker agrees with the assessment of the trial data. “Eisai’s interpretation of the data from the (safety clinical) trial differs from that of the FDA,” the drugmaker said in a statement posted on its website. “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.”
Read the FDA statement
