Eisai Co., Ltd. announced that the US Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for a once-daily formulation of its antiobesity agent Belviq (lorcaserin hydrochloride, “lorcaserin”) which has the potential to offer patients the convenience of once-daily treatment.

Acceptance of the application indicates that the FDA has found the submission to be sufficiently complete to review and that the FDA will begin conducting its assessment of the application. This NDA was submitted to the FDA by Arena Pharmaceuticals, Inc., with whom Eisai and its US subsidiary Eisai Inc. have a marketing and supply agreement. Upon FDA approval, Eisai will be responsible for commercializing the once-daily formulation in the United States.

A twice-daily formulation of lorcaserin was approved by the FDA in 2012 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related co-morbid condition, and has been available to patients in the United States under the brand name Belviq since June 2013.

Through Belviq, Eisai will continue to make further contributions to address unmet medical needs that exist in the clinical management of obesity and increase the benefits for patients and their families.