Eisai and Arena Pharmaceuticals Get Regulatory Approval For VENESPRI in Mexico

Arena Pharmaceuticals, Inc.

and Eisai Inc. revealed Thursday that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) has given its approval for the chronic weight management agent VENESPRI. It would proceed for commercialization by Eisai Laboratorios, S. de R.L. de C.V. (Eisai Mexico) in Mexico. Arena and Eisai said that VENESPRI is currently approved in Mexico as an adjunct to a reduced-calorie diet, as well as, increased physical activity for chronic weight management in adult patients with a body mass index (BMI) of 30 kg/m2 or greater (obese). According to them, patients with a BMI of 27 kg/m2 or higher or overweight with minimum one weight-related medical condition like high blood pressure, high cholesterol, or type 2 diabetes, were also eligible to be treated with VENESPRI. The companies indicated that the product would become available later this year. As a result of the latest regulatory approval, Arena would get a $1 million milestone payment. Arena's SVP of Operations and Head of Global Regulatory Affairs, Craig Audet, said, "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." Eisai CEO, Shaji Procida, reacted to the approval saying, "Currently more than 70 percent of the Mexican population is either overweight or obese. Without intervention, these numbers are projected to increase. Eisai remains committed to help address the health care needs of this patient population." Following this, the stock traded 3.75 percent up on Thursday.