The FDA has approved Eisai and Arena Pharmaceuticals’ New Drug Application (NDA) for BELVIQ XR (lorcaserin HCl) CIV extended-release 20mg tablets. The new formulation of lorcaserin will offer patients a once-a-day dosing option that may help them achieve and maintain weight loss. BELVIQ XR is expected to be available in the fall of 2016. In connection with the approval, Arena will receive a $10 million milestone payment.
BELVIQ XR is proven to be slowly absorbed in the body and lasts throughout the day. Both the original 10mg twice-daily formulation of BELVIQ and newly-approved 20mg once-daily extended release formulation are approved for use with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition, such as high blood pressure, high cholesterol, or type 2 diabetes. It is not known if BELVIQ or BELVIQ XR, when taken with other prescription, over-the-counter, or herbal weight-loss products, is safe and effective. It is not known if BELVIQ or BELVIQ XR changes your risk of heart problems, stroke, or death due to heart problems or stroke.
"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," said Louis J. Aronne, M.D., 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. "Having a once-daily treatment may offer an option for patients to stay on track to meet their weight loss goals."
The bioequivalence and bioavailability of once-daily BELVIQ XR 20mg compared with twice-daily BELVIQ 10mg was based on two phase I registrational clinical trials among healthy adult subjects. The most common treatment-emergent adverse events were similar to those seen in the phase III clinical trials of BELVIQ 10mg twice-daily.
"We're excited to offer this once-a-day option of lorcaserin," said Andrew Satlin, M.D., executive vice president, Neurology Business Group, Eisai. "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. The development of this new formulation further underscores Eisai's ongoing commitment to help address the health care needs of this underserved population."
"We are pleased that once-daily BELVIQ XR has been approved by the FDA and will provide patients another option for weight loss," said Amit D. Munshi, Arena's president and chief executive officer. "The approval of this new formulation is another example of Arena's success in supporting our collaborators."
