eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that the u.s. food and drug administration (fda) has approved a new drug application (nda) for belviq xr®, a once-daily formulation of lorcaserin hydrochloride (generic name, u.s. brand name: belviq®) for chronic weight management. belviq xr is scheduled for launch in autumn 2016.
belviq xr is a sustained release formulation which enables once-daily treatment, increasing the convenience of administration compared to twice-daily belviq tablets. this approval was based on clinical data that confirmed bioequivalence of once-daily 20 mg belviq xr with twice-daily 10 mg belviq tablets. eisai believes belviq xr will offer patients the potential benefits of the full fda approved 20 mg dose in a simple once daily tablet.
this approval was obtained by arena pharmaceuticals, inc. (headquarters: california, united states, president and ceo: amit d. munshi, “arena”), whom eisai and its u.s. subsidiary eisai inc. have an exclusive licensing agreement with to commercialize lorcaserin hydrochloride.
belviq 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 since june 2013. in july 2016, lorcaserin hydrochloride was approved in mexico under the brand name venespri®.
through obtaining approval for belviq xr, eisai continues to make further contributions to address unmet medical needs in the clinical management of obesity and increase the benefits for patients and their families.