14.07.2016 14:14:41
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Eisai And Arena Pharma Announce Regulatory Approval Of VENESPRI In Mexico
(RTTNews) - Eisai Inc. and Arena Pharmaceuticals Inc. (ARNA) 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.
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.
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.
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