ZIMULTI SANOFI-AVENTIS NDA 21-888. Endocrinologic and Metabolic Drugs Advisory Committee Meeting Silver Spring, Maryland June 13, 2007 Amy G. Egan, M.D., M.P.H. Division of Metabolism and Endocrine Products. Center for Drug Evaluation and Research. Outline.
Endocrinologic and Metabolic Drugs Advisory Committee Meeting
Silver Spring, Maryland
June 13, 2007
Amy G. Egan, M.D., M.P.H.
Division of Metabolism and Endocrine Products
Center for Drug Evaluation and Research
As of 18 December 2006, the cumulative database for rimonabant consists of:
1 Completed suicide
2 Suicide attempt
3 Preparatory acts toward imminent suicide behavior
4 Suicidal ideation
5 Self-injurious behavior, intent unknown
6 Not enough information (fatal)
9 Not enough information (non-fatal)
Weight loss Mood (RIO)
Yet to be identified
Yet to be identifiedBenefit vs. Harm
Medical Review Team Pharmacology/Toxicology
Eric Colman, M.D. John Gong, Ph.D.
Mary Parks, M.D. Karen Davis-Bruno, Ph.D.
Statistical Review Team
Lee Ping Pian, Ph.D.
J. Todd Sahlroot, Ph.D.
1. Please discuss your level of concern regarding rimonabant and psychiatric adverse events, in particular depression and suicidality, and neurological adverse events, in particular seizures, and the reasons behind your thinking on these issues.
2a. Do you believe that the currently available data sufficiently characterize rimonabant’s safety profile (vote requested)?
2b. If no, please discuss what additional data should be obtained.
3a. Based on the currently available data, do you believe rimonabant has a favorable risk-benefit profile and should be approved for the indication of weight management in individuals with a body mass index of > 30 kg/m2 and > 27 kg/m2 when accompanied by at least one comorbid condition (vote requested)?
3b. If no, please explain why and discuss what additional information the sponsor could obtain that might improve rimonabant’s risk-benefit profile.