The FDA has requested that Eisai, the manufacturer of Belviq, Belviq XR (lorcaserin), voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. Eisai Inc. has submitted a request to voluntarily withdraw the drug.
The FDA approved lorcaserin in 2012, with the requirement that Eisai conduct a clinical trial to evaluate the risk of cardiovascular problems. This trial was the five-year, 12,000-patient study, CAMELLIA-TIMI 61. 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. However, 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. A range of cancer types was observed, with several different types of cancers occurring more frequently in the lorcaserin group, including pancreatic, colorectal, and lung.
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. A Drug Safety Communication was issued informing patients to stop using the medication Belviq and Belviq XR (lorcaserin) and talk to their health care professionals about other treatment options for weight loss.”
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.”
About Belviq, Belviq XR (lorcaserin)
Lorcaserin is a serotonin 2C receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: • 30 kg/m2 or greater (obese) (1) or • 27 kg/m2 or greater (overweight) in the presence of at least one weight related comorbid condition, (e.g., hypertension, dyslipidemia, type 2 diabetes).Source: U.S. Food & Drug Administration