Eisai Co. Ltd. is removing Belviq (lorcaserin) from the U.S. market due to the FDA’s concerns about an increased occurrence of cancer in a long-term trial evaluating the cardiovascular effects associated with the weight-loss drug.

While the randomized, double-blind, placebo-controlled CAMELLIA-TIMI 61 trial showed Belviq helped with sustained weight loss without a higher rate of major cardiovascular events, the FDA noted there was an imbalance in the number of patients with malignancies. The agency's analysis of the study found that during the course of the trial, 462 (7.7%) patients treated with Belviq were diagnosed with cancers compared with 423 (7.1%) in the placebo group.

“Our review of the full clinical trial results shows that the potential risk of cancer associated with the drug outweighs the benefit of treatment,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. She noted that earlier this year, the agency issued an alert about the possible risk of cancer associated with the drug based on its preliminary analysis of the trial data.

At the time of that alert, the FDA said since the cause of the cancer was uncertain, it couldn’t conclude that lorcaserin contributes to the risk.

Tokyo-based Eisai has a different interpretation of the trial results, saying its assessment is that Belviq and Belviq XR “continue to have a positive benefit-risk profile in the patient population for which they are indicated.” However, the company said it respects the FDA's decision and is working closely with the agency on the withdrawal process.

As part of the withdrawal, the FDA is advising patients to stop taking Belviq and Belviq XR and to talk to their doctors about alternative weight-loss drugs and weight-management programs.

The CAMELLIA-TIMI 61 trial was the largest cardiovascular outcome trial conducted to date for a weight-loss drug. Conducted at more than 400 sites in eight countries, including the U.S., the trial was to enroll about 12,000 men and women over five years with established cardiovascular disease or at high risk for cardiovascular disease.

Belviq was approved in 2012 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults who were obese or who were overweight and had at least one weight-related co-morbid condition.

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