Center for Drug Evaluation and Research



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


Human Pharmacology Vijay Bhargava, Ph.D.

Senior Director, Drug Metabolism and



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.


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