FDA approves Arena's lorcaserin

Arena Pharmaceuticals Inc. (NASDAQ:ARNA) jumped $2.54 (29%) to $11.39 on Wednesday after FDA approved an NDA 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) said the pharma will announce a launch timeline for Belviq after the DEA completes its review of the drug, which Arena estimates will take four to six months. The pharma has not yet determined the price of the drug. The approval triggers a $20 million milestone payment to Arena from Eisai. The partners said Belviq is the first obesity drug approved by FDA in 13 years. Arena's stock move translates to a $500.8 million increase in market cap. The company's market cap is now $2.2 billion.

The serotonin (5-HT2C) receptor agonist is approved for use in adults with a BMI of 30 kg/m2 or greater, or adults with a BMI of 27 kg/m2 or greater who have at least one 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. ...