Arena Pharmaceuticals and Eisai have announced FDA approval of Belviq (lorcaserin HCl) for chronic weight management in adults who are overweight with comorbidity or obese.
The FDA approved Belviq 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 30kg/m2 or greater (obese), or 27kg/m2 or greater (overweight) in the presence of at least one weight related comorbid condition.
The effect of Belviq on cardiovascular morbidity and mortality, and the safety and efficacy of coadministration of Belviq with other products intended for weight loss have not been established.
Eisai president and chief executive officer Lonnel Coats said, "Belviq represents an important therapeutic option for physicians responsible for the medical management of their patients who are overweight or obese."
The FDA has recommended the US Drug Enforcement Administration (DEA) to classify Belviq as a scheduled drug.
Upon the final scheduling designation provided by DEA, Eisai will announce the availability of Belviq to patients and physicians in the US.
Arena will manufacture and supply the finished commercial product from its Switzerland facility while Eisai will market and distribute Belviq in the US.
