Eisai indicated it was voluntarily withdrawing the drug, but in a statement noted it disagreed with the FDA’s interpretation of the data and believes the drug’s benefits outweigh the cancer risk.
The U.S. Food and Drug Administration (FDA) has called for Eisai to pull its weight loss drug Belviq from the market after clinical trials demonstrated an increased incidence of cancer in users. It applies to Belviq and Belviq XR.
Eisai, headquartered in Japan, indicated it was voluntarily withdrawing the drug, but in a statement noted it disagreed with the FDA’s interpretation of the data and believes the drug’s benefits outweigh the cancer risk. “Eisai respects the FDA’s decision and is working closely with the Agency on the withdrawal process,” the company told CNN.
The FDA, on the other hand, warned patients to stop taking the drug immediate, throw out leftover pills and see their doctor for alternatives. The agency also told doctors to advise their patients to stop taking the drug.
Belviq was approved in 2012. The FDA required Eisai to run a clinical trial to evaluate the risk of cardiovascular problems. The study was recently completed and the full data analyzed. The agency indicates, “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.”
The agency is not recommending special screening for patients taking the drug but suggest consulting with your physician if you have questions.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement, the “potential risk of cancer associated with the drug outweighs the benefit of treatment. As noted in a new Drug Safety Communication issued today, patients should stop using the medication Belviq and Belviq XR (lorcaserin) and talk to their health care professionals about other treatment options for weight loss.”
Belviq came out at approximately the same time as several other weight loss drugs did. The Japan Times notes that although expectations for them to become blockbusters was high, none of them were. Belviq was noted for being the first to help patients lose weight and maintain the weight loss for several years without increasing the risk of heart problems. That was the conclusion of a five-year, 12,000-patient study, CAMELLIA-TIMI 61, the FDA required the company to run.
But recently the final analysis showed 7.7% of patients in the study who took Belviq were diagnosed with cancer, slightly higher than the 7.1% in the placebo cohort. Eisai believes the benefit-risk profile is still good but is complying with the FDA request.
“Eisai’s interpretation of the data from the CAMELLIA-TIMI 61 trial differs from that of the FDA,” Eisai said in a statement. “We assess that Belviq and Belviq XR continue to have a positive benefit-risk profile in the patient population for which they are indicated.”
The drug is approved for adults with a body mass index (BMI) of 30 and adults with a BMI of 27 who have other conditions with increased cardiovascular risks, such as high blood pressure, high cholesterol or Type 2 diabetes.
According to IQVIA, in 2018 Belviq brought in $8.2 million. It was the top position in the market but has since lost market share to Novo Nordisk’s Saxenda.
