The US Food and Drug Administration (FDA) has approved Belviq (pronounced BEL-VEEK) 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 comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).
Arena Pharmaceuticals, Inc. will manufacture and supply the finished commercial product from its facility in Switzerland, and Eisai Inc. will market and distribute Belviq in the United States.
The indication includes the following limitations of use: The safety and efficacy of coadministration of Belviq with other products intended for weight loss and the effect of Belviq on cardiovascular morbidity and mortality have not been established.
“The FDA approval of Belviq is an important development for patients who struggle with obesity or are overweight with comorbidities and need help with chronic weight management beyond diet and exercise,” said Jack Lief, Arena's president and CEO. “We thank our entire team and the patients who participated in our clinical trial programme for making this achievement possible.”
Three double-blind, randomized, placebo-controlled trials demonstrated that Belviq along with diet and exercise was more effective than diet and exercise alone at helping patients lose five per cent or more of their body weight after one year and managing the weight loss for up to two years.
“Diet, exercise and behavioral therapy alone may not result in sustained weight loss for many overweight and obese people trying to lose weight,” said Lonnel Coats, president and chief executive officer, Eisai Inc. “ Belviq represents an important therapeutic option for physicians responsible for the medical management of their patients who are overweight or obese.”
In clinical trials, the most common adverse reactions for patients without diabetes treated with Belviq were headache, dizziness, fatigue, nausea, dry mouth, and constipation. In patients with diabetes, the most common adverse reactions were hypoglycemia, headache, back pain, cough, and fatigue.
The FDA has recommended that Belviq be classified by the US Drug Enforcement Administration (DEA) as a scheduled drug. The DEA will review the FDA's recommendation and determine the final scheduling designation. Once the DEA has provided the final scheduling designation, Eisai will announce when Belviq will be available to patients and physicians in the United States.
As part of the approval of Belviq, the companies committed to conduct post-marketing studies to assess the safety and efficacy of Belviq for weight management in obese pediatric patients, as well as to evaluate the effect of long-term treatment with Belviq on the incidence of major adverse cardiovascular events in overweight and obese subjects with cardiovascular disease or multiple cardiovascular risk factors. The cardiovascular outcomes trial will include echocardiographic assessments.
Belviq (lorcaserin hydrochloride) is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain.
The Belviq phase III clinical trial programme consisted of three double-blind, randomized, placebo-controlled trials: BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) and BLOOM-DM (Behavioural modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus). All three trials included a standardized programme of diet, moderate exercise and behavioural counseling for both the placebo and Belviq groups.