Arena (ARNA) Confirms FDA Approval of BELVIQ
Tweet Send to a Friend
Up)
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today that the U.S. 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). 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 (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.
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.
Arena will host a conference call and webcast today, June 27, 2012, at 2 p.m. Eastern Time (11 a.m. Pacific Time) to provide a business update. The conference call may be accessed by dialing 877.643.7155 for domestic callers and 914.495.8552 for international callers.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
"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 (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.
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.
Arena will host a conference call and webcast today, June 27, 2012, at 2 p.m. Eastern Time (11 a.m. Pacific Time) to provide a business update. The conference call may be accessed by dialing 877.643.7155 for domestic callers and 914.495.8552 for international callers.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
You May Also Be Interested In
- EMA Approves MAA for Gilead's (GILD) Sofosbuvir
- SkyWest (SKYW), United (UAL) Enter CPA for 40 E175s
- UPDATE: Senate Takes Aim at Apple (AAPL); Says Irish Unit Earned $22B, Paid $10M in Taxes
Create E-mail Alert Related Categories
Corporate News, FDA
Login with Facebook
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
