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news.Eisai and Arena Pharmaceuticals announced that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) has granted regulatory approval of the chronic weight management agent VENESPRI (lorcaserin HCl: U.S. brand name: BELVIQ) for commercialization by Eisai Laboratorios, S. de R.L. de C.V. (Eisai Mexico) in Mexico.
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VENESPRI is now approved in Mexico as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with a body mass index (BMI) of 30 kg/m2 or greater (obese).
Patients with a BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes, are also eligible to be treated with VENESPRI. The product is expected to become available later this year. In connection with the approval Arena will receive a $1 million milestone payment.
"Currently more than 70 percent of the Mexican population is either overweight or obese," said Shaji Procida, President and Chief Operating Officer, Eisai Inc.
"Without intervention, these numbers are projected to increase. Eisai remains committed to help address the health care needs of this patient population."
In addition to Mexico, lorcaserin HCl is also approved for weight management in the United States and in South Korea, where it is marketed under the name BELVIQ.
Eisai and Ildong Pharmaceutical Co., Ltd., market and distribute BELVIQ in the United States and South Korea, respectively. Arena manufactures and supplies the finished commercial product from its facility in Switzerland.
"We are pleased that the Mexican health authority has approved VENESPRI as an option for patients who find it difficult to lose weight through diet and exercise alone," said Craig M. Audet, Ph.D., Senior Vice President of Operations & Head of Global Regulatory Affairs, Arena Pharmaceuticals, Inc.
About VENESPRI (lorcaserin HCl) BELVIQ CIV (in the United States)) for Chronic Weight Management
VENESPRI is a serotonin 2C receptor agonist approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes.
It is not known if VENESPRI is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products, nor is it known if VENESPRI changes the risk of heart problems or stroke, or death due to heart problems or stroke.
The safety and efficacy of coadministration of VENESPRI with other products intended for weight loss, including prescription drugs (e.g., phentermine), over-the-counter drugs and herbal preparations have not been established. The effect of VENESPRI on cardiovascular morbidity and mortality has not been established.