Eisai seeking earlier access for Belviq

Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) sent a letter late last week to the U.S. Drug Enforcement Agency requesting that the agency allow Belviq lorcaserin from partner Arena Pharmaceuticals Inc. (NASDAQ:ANRA) to be available immediately once the agency publishes its final classification of the obesity drug. Last Wednesday, the DEA proposed classifying Belviq as a class IV scheduled drug, where class I indicates the highest potential for abuse and class V the lowest. Comments on the proposal are due Jan. 18, 2013. Belviq will not be available until the DEA's final rule takes effect, which under federal regulations is no sooner than 30 days from the publication of the final rule unless "conditions of public health or safety necessitate an earlier effective date."

Eisai said in its letter that public health necessitates an earlier effective date for Belviq's scheduling, noting that obesity is the third leading cause of preventable death after tobacco and high blood pressure. The pharma also noted that obesity is an independent risk factor for Type II diabetes and increases the risk for long-term complications of diabetes. Eisai noted in its letter that the DEA has waived the 30-day minimum period for other drugs, including most recently Potiga ezogabine from Valeant Pharmaceuticals International Inc. (NYSE:VRX; TSX:VRX). ...