Arena Pharmaceuticals and Eisai Announce FDA Approval of BELVIQ® (lorcaserin HCl) for Chronic Weight Management in Adults who are Overweight with a Comorbidity or Obese
- First Prescription Weight-Loss Treatment Approved by FDA in 13 Years
- Eisai to Launch BELVIQ in U.S. Following DEA’s Completion of Scheduling Review
Arena Pharmaceuticals, Inc.(NASDAQ: ARNA) andEisai Inc.announced today that theU.S. 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/m2or 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). 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,” saidJack 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,” saidLonnel 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.
TheFDAhas recommended that BELVIQ be classified by theU.S. Drug Enforcement Administration(DEA) as a scheduled drug. The DEA will review theFDA’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 inthe United States.
Arena will manufacture and supply the finished commercial product from its facility inSwitzerland, and Eisai will market and distribute BELVIQ inthe 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.
Read the full Press Release at http://invest.arenapharm.com/releasedetail.cfm?ReleaseID=687182