FDA: SANOFI-AVENTIS' ACOMPLIA NOT APPROVABLE FOR SMOKING CESSATION
The FDA has handed down a split decision on sanofi-aventis' experimental weight-loss and smoking-cessation drug Acomplia.
The agency's Division of Metabolism and Endocrinology Products issued an approvable letter for Acomplia (rimonabant) for weight management, the firm said recently. But the FDA's Division of Anesthesia, Analgesia and Rheumatology Products issued a nonapprovable letter for smoking cessation.
"Sanofi-aventis will continue to work in close collaboration with the FDA," the company said. The drug is the first in a new class of therapeutic agents called CB1 blockers, it added.
The company has said it expects to launch the drug by the second quarter of this year. Acomplia has been linked to anxiety and depression in some clinical trial patients. The global obesity-drug market is expected to increase from the current $800 million to more than $2.5 billion by 2010, analysts say.