European drug regulators are leery about approving the new weight loss drug Belviq because of safety concerns, including heart valve problems and psychiatric side effects in patients, and tumors observed during studies on lab rats.
Belviq is currently under review by an advisory panel for the European Medicines Agency (EMA), which is expected to make a recommendation for the EMA by March whether to approve the drug. Arena Pharmaceuticals, the drug’s maker, has been working with the agency to answer questions and clear up any matters that stand in the way of approval. But its chances may be slim.
The committee last fall refused to recommend the approval of Vivus Inc.’s Qsiva, sold in the U.S. as Qsymia, because of concerns about the long-term effects on the heart and blood vessels. The drug may also increase the risk for birth defects in women who are pregnant or become pregnant while taking the medication.
The EMA is not required to follow the recommendation of its advisory board, but it usually does. Perhaps European regulators are waiting for the U.S. to flesh out any problems with the new weight loss pills.
The U.S. Food and Drug Administration (FDA) approved Belviq last year, making it the first diet pill to be approved in the U.S. in 13 years. Soon after, the agency also approved Qsymia. Qsymia went on sale late last year, but Belviq isn’t expected to hit the market until the end of 2013. Both pills are considered lifelong treatments for obese and overweight people 18 years or older who cannot control their weight through diet and exercise alone.
Both pills were approved by the FDA on the condition that the makers of the drugs perform long-term trials to examine the effects of the medications on the heart.