Eisai Weight-Management Drug Gets FDA ApprovalBy
Eisai has received US Food and Drug Administration (FDA) approval for Belviq XR (lorcaserin hydrochloride), a once-daily formulation of Belviq, for chronic weight management. Belviq XR is scheduled for launch in the autumn of 2016.
The approval was obtained by San Diego, California-based Arena Pharmaceuticals, which discovered and developed the drug and with which Eisai and its US subsidiary, Eisai Inc., have an exclusive licensing agreement to commercialize lorcaserin hydrochloride.
Belviq was first approved in the US 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 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. It has been available to patients in the US since June 2013. In July 2016, lorcaserin hydrochloride was approved in Mexico under the brand name Venespri with the same indication as for the US.
The agreement granting Eisai exclusive rights to market and distribute lorcaserin hydrochloride in 21 countries throughout the Americas was expanded in November 2013 to include most countries and territories worldwide, including the European Union, Japan, and China, though excluding South Korea, Taiwan, Australia, New Zealand and Israel.