Anti-Infective Drugs Advisory Committee in Joint Session with the Drug Safety and Risk Management Advisory Committee

December 14, 2006

The Committee discussed the overall benefit to risk considerations for the approved product KETEK (telithromycin), new drug application (NDA) 21-144, with the current indications of: acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis, and community acquired pneumonia, manufactured by Sanofi-Aventis.

Slides

FDA

Welcome & Introductory Comments/Purpose Edward Cox, M.D., M.P.H., Acting Director, Office of Antimicrobial Products, CDER, FDA (PPT) (HTM)

Respiratory Tract Infections: Epidemiology/Treatment John Bartlett, M.D., Professor of Medicine Johns Hopkins School of Medicine (PPT) (HTM)

DAIOP Presentation of Ketek Data & Review Regulatory History, Janice Soreth, M.D., Director, Division of Anti-Infective and Ophthalmology Products, FDA (PPT) (HTM)

Pre-Approval Efficacy and Safety Data, John Alexander, M.D., Clinical Team Leader, Division of Anti-Infective and Ophthalmology Products, FDA (PPT) (HTM)

5 years post-marketing ex US. Orjan Mortimer, M.D., MPA Clinical Assessor, Senior Expert, Pharmacovigilance Unit, Medical Products European Medicines Agency (EMEA), Uppsala, Sweden (PPT) (HTM)

Data-Mining Evaluation of AERS/ Multiple Antibiotics, Jonathan G. Levine, Ph.D., Mathematical Statistician, Office of Critical Path Programs, Office of the Commissioner, FDA (PPT) (HTM)

OSE Analyses of Hepatic Adverse Events, Allen Brinker, M.D., M.S., Epidemiology Team Leader, Office of Surveillance and Epidemiology, CDER, FDA (PPT) (HTM)

Assessment of Causality in Drug-Induced Hepatotoxicity, Leonard Seeff, M.D., Senior Investigator, Division of Digestive Diseases and Nutrition, National Institutes of Diabetes and Digestive and Kidney Diseases, NIH (PPT) (HTM)

Review of Clinical Cases and Perspective, William Lee, M.D., Director, Clinical Center for Liver Diseases, University of Texas Southwestern Medical School (PPT) (HTM)

Sponsor Presentation

Introductory remarks Mark Moyer, MS, Deputy Head, and VP, RD (PDF)

Medical need and resistance Don E. Low, M.D., FRCPC, Professor, Department of Laboratory Medicine and Pathobiology and Department of Medicine, University of Toronto, Ontario, Canada (PDF)

Overview of approval activities, Helen Edelberg, M.D., M.P.H., Associate Therapeutic Area Head, Anti-Infectives, RD (PDF)

Microbiologic surveillance, Stephen G. Jenkins, Ph.D., Clinical Professor of Pathology and Director, Clinical Microbiology Laboratories, Mount Sinai school of Medicine, New York, NY (PDF)

Clinical Importance of Ery-resistant S. pneumoniae, John R. Lonks, M.D, Associate Professor of Medicine Brown University Medical School (PDF)

Clinical safety, Barbara Rullo, M.D., Therapeutic Area Head, GPE (Marketed Products) (PDF)

Adverse events of Special interest: Hepatic Safety overview, Barbara Rullo, M.D., Therapeutic Area Head, GPE (Marketed Products) (PDF)

Expert review, James H. Lewis, M.D., FACP, FACG, Professor of Medicine and Director of Hepatology Georgetown University Medical Center Washington, D.C (PDF)

Epdemiologic investigations – PHARMetrics, Wanju Dai, M.D., Dr.PH., Head, Epidemiology, Global Pharmacovigilance &Epidemiology (GPE) (PDF)

Epidemiological investigation – Ingenix, Alexander M. Walker, Dr.PH., Senior VP Epidemiology, i3 Drug Safety, Adjunct Professor of Epidemiology, Department of Epidemiology, Harvard School of Public Health, Boston, MA (PDF)

Expert review of epidemiology, Judith Jones, M.D. Ph.D., Ph.D., President, CEO, The Degge Group, Arlington, VA, Adjunct Professor of Pharmacology, Georgetown School of Medicine, Washington, D.C. (PDF)

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