FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE (AIDAC) MEETING
AGENDA
January 8, 2003
Marriott Washingtonian Center, Grand Ballroom, 9751 Washingtonian Blvd., Gaithersburg, MD
NDA 21-144, Ketek™ (telithromycin), Aventis Pharmaceuticals, Inc., proposed for treatment of community-acquired pneumonia, acute exacerbation of chronic bronchitis, and acute maxillary sinusitis
8:00 a.m. Call to Order James E. Leggett, Jr., M.D.
Acting Chair, AIDAC
Introduction of Committee
Conflict of Interest Statement Tara P. Turner, Pharm.D.
Executive Secretary, AIDAC
8:05 a.m. Historical Background of Ketek™ NDA Janice Soreth, M.D. Director
Division of Anti-Infective Drug Products
Food and Drug Administration
8:20 a.m. Clinical Significance of Macrolide Resistance John H. Powers, M.D.
Lead Medical Officer for
Antimicrobial Drug Development
Office of Drug Evaluation IV
Food and Drug Administration
8:50 a.m. Sponsor Presentation Aventis Pharmaceuticals, Inc.
Introduction Steve Caffé, M.D.
Head, U.S. Regulatory Affairs
Medical Need Paul Ianinni, M.D.
Clinical Professor of Medicine
Yale University School of Medicine
Microbiology Stephen Jenkins, Ph.D.
Director of Clinical Microbiology
Carolinas Medical Center
Clinical Efficacy Bruno Leroy, M.D.
Senior Director, Clinical Development
Anti-Infectives
Human Pharmacology Vijay Bhargava, Ph.D.
Senior Director, Drug Metabolism and
Pharmacokinetics
Clinical Safety Paul Lagarenne, M.D.
Vice-President, Clinical Safety Analysis
Global Pharmacovigilance
Conclusions Paul Ianinni, M.D.
10:35 a.m. Break
10:50 a.m. FDA Presentation
Efficacy of Telithromycin John Alexander, M.D., M.P.H.
Medical Team Leader
Division of Anti-Infective Drug Products
Safety Summary – Phase 3 Charles Cooper, M.D.
Medical Officer
Division of Anti-Infective Drug Products
Study 3014 - Safety C. George Rochester, Ph.D.
Statistician
Division of Biometrics III
Hepatic Pathology Discussion David Kleiner, M.D., Ph.D.
Laboratory of Pathology
National Cancer Institute
National Institutes of Health
Post-Marketing Information Charles Cooper, M.D.
12:30 p.m. Lunch
1:30 p.m. Open Public Hearing
2:00 p.m. Committee Discussion and Vote
5:00 p.m. Adjourn