The FDA approved a new drug application for extended-release Belviq XR, offering a once-daily dosing option to help patients with obesity achieve weight loss, Eisai Inc. and Arena Pharmaceuticals Inc. announced in a press release.
The new formulation of Belviq (lorcaserin), available as 20-mg tablets, is expected to be available this fall. In connection with the approval, Arena will receive a $10 million milestone payment.
Lorcaserin is believed to work by activating select serotonin 2C brain receptors, thus mimicking satiety and reducing food consumption. The twice-daily formulation of the drug was approved in 2013.
Louis J. Aronne
“With approximately two-thirds of the U.S. population living with extra weight or obesity, there is a significant and growing need to address chronic weight management,” Louis J. Aronne, MD, director of the comprehensive weight control center at Weill Cornell Medicine, physician at New York-Presbyterian/Weill Cornell Medical Center and principal investigator of the Belviq clinical trials, said in the release. “Having a once-daily treatment may offer an option for patients to stay on track to meet their weight loss goals.”
Both the original, 10-mg twice-daily formulation and newly approved 20-mg once-daily extended-release formulation of the drug are approved for use with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a BMI of at least 30 kg/m² or a BMI of at least 27 kg/m² with at least one weight-related comorbidity, including hypertension, hyperlipidemia or type 2 diabetes.
It is not known whether lorcaserin when taken with other prescription, over-the-counter or herbal weight-loss products is safe and effective, or if the drug in either formulation changes a patient’s risk for heart problems, stroke or death.
The bioequivalence and bioavailability of once-daily lorcaserin 20-mg compared with twice-daily lorcaserin 10 mg was based on two phase 1 clinical trials among healthy adults. The most common treatment-emergent adverse events were similar to those seen in the phase 3 clinical trials of twice-daily lorcaserin.
“This option may provide another choice for patients who are overweight or obese and find it difficult to lose weight through diet and exercise alone,” Andrew Satlin, MD, executive vice president, Neurology Business Group, Eisai Inc., said in a statement.