The FINANCIAL -- Arena Pharmaceuticals and Eisai Inc. announced that the U.S. Food and
Drug Administration has 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 30 kg/m2 or greater, or 27 kg/m2 or greater
in the presence of at least one weight related comorbid
According to Arena Pharmaceuticals, 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 Chief Executive Officer. "We thank our entire team and the patients who participated in our clinical trial program 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 5% 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 U.S. Drug Enforcement Administration 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.
Arena will manufacture and supply the finished commercial product from its facility in Switzerland, and Eisai will market and distribute BELVIQ 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.