Belviq lorcaserin regulatory update

FDA approved an NDA from Arena for Belviq lorcaserin for chronic weight management. The agency recommended the U.S. Drug Enforcement Administration classify Belviq as a class IV scheduled drug, where class I indicates the highest potential for abuse and class V the lowest. Arena and marketing partner Eisai Co. Ltd. (Tokyo:4523; Osaka:4523, Tokyo, Japan) said the pharma will announce a launch timeline for Belviq after the DEA completes its review of the drug, which Arena estimates will take 4-6 months. The pharma has not yet determined the price of the drug. The approval does not require a REMS for Belviq. The partners said Belviq is the first obesity drug approved by FDA in 13 years.

The serotonin (5-HT2C) receptor agonist is approved for use in adults with a BMI of 30 kg/m 2 or greater, or adults with a BMI of 27 kg/m 2 or greater who have at least 1 weight-related condition. Belviq's label recommends the drug be discontinued in patients who fail to lose 5% of their body weight after 12 weeks of treatment. Based on data from the Phase III BLOOM, BLOOM-DM and BLOSSOM trials, Arena said about 42% of patients without Type II diabetes and 32% of Type II diabetics achieved 5% weight loss at 12 weeks. ...