Joint meeting of the Anti-Infective Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

December 14 & 15, 2006

Briefing Information

Ketek (telithromycin) NDA 21-144

Sanofi-Aventis U.S. LLC

Table of Contents for NDA 21-144 Briefing Package

• Briefing Document (pdf)
  • EXECUTIVE SUMMARY
  1. INTRODUCTION
  2. DESCRIPTION OF TELITHROMYCIN
  3. PUBLIC HEALTH NEED
     3.1 BURDEN OF DISEASE
     3.2 CURRENT ANTIBIOTIC TREATMENT OF RESPIRATORY TRACT INFECTIONS AND THEIR LIMITATIONS
  4. US SUMMARY OF PREAPPROVAL DATA
     4.1 INVESTIGATIONAL NEW DRUG APPLICATION
     4.2 PREAPPROVAL: MICROBIOLOGY DATA
     4.3 PREAPPROVAL: CLINICAL PHARMACOLOGY DATA
     4.4 PREAPPROVAL: EFFICACY DATA
     4.5 PREAPPROVAL: SAFETY DATA
  5. US APPROVAL PROCESS
     5.1 NEW DRUG APPLICATION
     5.2 ADVISORY COMMITTEE MEETING (APRIL 26, 2001)
     5.3 FIRST FDA APPROVABLE LETTER (DATED JUNE 1, 2001)
     5.4 ADVISORY COMMITTEE MEETING (JANUARY 8, 2003)
     5.5 SECOND FDA APPROVABLE LETTER (DATED JANUARY 24, 2003)
     5.6 FDA APPROVAL LETTER (DATED APRIL 1, 2004)
  6. US POSTAPPROVAL DATA
     6.1 POSTAPPROVAL: MICROBIOLOGY DATA
     6.2 POSTAPPROVAL: EFFICACY DATA
     6.3 POSTAPPROVAL: SAFETY DATA
     6.4 POSTAPPROVAL: LABELING CHANGES
     6.5 EPIDEMIOLOGY
  7. BENEFIT/RISK ASSESSMENT
     7.1 INTRODUCTION
     7.2 MEDICAL NEED
     7.3 BENEFITS
     7.4 RISKS
  8. CONCLUSIONS OF BENEFIT/RISK ASSESSMENT
  9. REFERENCES
     
     APPENDIX A: BIOSTATISTICAL METHODS (pdf)
     
     APPENDIX B: PHASE III SAFETY DATA (pdf )
     
     Deaths in controlled studies
     Deaths in open-label studies
     Narratives: Deaths in controlled Phase III studies
     Narratives: Deaths in open-label Phase III studies
     Criteria of clinically noteworthy abnormal laboratory values (CNALV)
     QTc interval data for telithromycin vs. comparators
     Narratives for serious hepatic cases
     Narratives for serious syncope cases \
     
     APPENDIX C: POSTMARKETING SAFETY METHODS (pdf)
     
     PMS Methodology
     AESI checklist for visual adverse events
     AESI form for hepatic events
     AESI form for cardiac adverse events
     
     APPENDIX D: FDA APPROVAL LETTER (pdf )
     
     APPENDIX E: MICROBIOLOGY (pdf)
     
     APPENDIX F: PHASE IV SAFETY DATA (pdf )
     
     Deaths reported in Phase IV studies
     Adverse events of special interest in Study A3503 (TELICAST)
     
     APPENDIX G: LABELING (pdf )
     
     USPI June 2006
     Dear Health Care Professional Letter
     SPC October 2006
     Post approval labeling modifications, US and EU (01-Apr-04 to 15-Sep-06)
     Post approval labeling modifications, EU (09-Jul-01 to 01-Apr-04)
     
     APPENDIX H: EPIDEMIOLOGY TABLES (pdf)
     
     Disproportionality analysis of the FDA FOI database for selected over the counter medications
     Disproportionality analysis of the FDA FOI database for selected antibiotics
     MedDRA terms used in the evaluation of each AESI
     Study report: PHARMetrics Integrated Outcome Database
     
     APPENDIX I: POSTMARKETING SURVEY (pdf )