Acomplia News fromDecember 2006 -- News about Rimonabant
Sanofi: FDA Action on Diet Drug Acomplia Not Expected Until April 26th
Sanofi-Aventis grudgingly conceded on Dec. 8th that the U.S. Food and Drug Administration has placed highly anticipated diet drug rimonabant (Acomplia / Zimulti) on a slow track for review, and said it now hopes for an FDA decision on approval of the diet pill by April 26th.
The encouraging results reported for Acomplia in its SERENADE diabetes trial earlier this week were tempered by news that one person in 17 (5.8 percent) of those taking Acomplia suffered from what was termed "depressed mood," compared to one person in 143 (0.7 percent) in the group taking a placebo.
The problem was serious enough for more than one-third of those suffering from depressed mood that they dropped out of the SERENADE study.
"We remain concerned about Acomplia's psychiatric profile, specifically regarding depression and anxiety," Bear Stearns analyst Alexandra Hauber said in a note to investment banking clients, adding that the FDA might well ask one of its independent panels of experts to weigh in on the drug.
The FDA panel that would consider Acomplia, the Endocrinologic and Metabolic Drugs Advisory Committee, has thus far not announced any plans to hold a public meeting on Acomplia in the first part of 2007.
We subscribe to the HONcode principles of the HON Foundation.
This is an independent news site reporting on rimonabant, a diet drug developed by Sanofi-Synthelabo Inc., which plans to market it under the trademarked name Acomplia. Nothing on this site is intended to infringe on that trademark. Nothing on this site is intended as medical advice. The information provided here is for informational purposes only. Always consult a doctor or medical professional with questions you may have regarding a medical condition.
(c) 2004-2006 Medical Week News, Inc. All Rights Reserved