CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

Holiday Inn

Silver Spring, MD

CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE

AGENDA

95^th Meeting

Thursday, January 17, 2002

8:30 Call to Order and Welcome: Jeffrey Borer, M.D., Chair

8:35 Conflict of Interest Statement: Jaime Henriquez, Executive Secretary

PRESENTATIONS:

8:40 NDA 20-757/S-021, Avapro® (irbesartan), Sanofi-Synthelabo (c/o Bristol-Myers Squibb), for the treatment of hypertensive patients with type 2 diabetic renal disease.

Sponsor’s Presentation:

Introduction: Brian F. Daniels, M.D., Vice President, Pharmaceutical Research Institute, Bristol-Myers Squibb

Disease Background: Edmund J. Lewis, M.D., Muehrcke Professor of Nephrology and Director of the Section of Nephrology, Rush Medical College, Chicago, IL

IDNT Efficacy and Safety: Melisa Cooper, M.D., M.S., Vice President, Pharmaceutical Research Institute, Bristol-Myers Squibb

IRMA 2 Efficacy and Safety: Hans-Henrik Parving, M.D., DMSc, Professor and Chief Physician, Steno Diabetes Center, Denmark

Benefit:Risk Assessment: Edmund J. Lewis, M.D.

9:45 Break

10:00 Committee Discussion and Review:

Committee Reviewer: JoAnn Lindenfeld, M.D.

12:00 Lunch

CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE

AGENDA CONTINUES

95^th Meeting

1:00 Meeting Open for Public Comments

2:00 Committee Discussion Continues

3:00 Break

4:30 Adjourn

Friday, January 18, 2002

8:30 Call to Order and Welcome: Jeffrey Borer, M.D., Chair

8:35 Conflict of Interest Statement: Jaime Henriquez, Executive Secretary

8:40 NDA 21-387, Pravastatin/Aspirin, Bristol-Myers Squibb, co-package, for long-term management to reduce the risk of death, nonfatal myocardial infarction, myocardial revascularization procedures, and ischemic stroke in patients with clinically evident coronary heart disease.

Sponsor’s Presentation:

Introduction: Fred Fiedorek, M.D., Vice President, Bristol-Myers Squibb

Efficacy & General Considerations: Rene Belder, M.D., Executive Director, Bristol-Myers

Squibb

Efficacy - Meta-Analyses: Donald A. Berry, Ph.D., Frank T. McGraw Memorial Chair of Cancer Research, University of Texas, M.D. Anderson Cancer Center

The Medical Need: Thomas A. Pearson, M.D., Ph.D., Albert D. Kaiser Professor of Community & Preventive Medicine, University of Rochester School of Medicine

9:45 Break

10:00 Appropriate Dose and Relationship to Cholesterol Lowering: Dr. Terje Pedersenm Cardiology Department, Aker University Hospital, Oslo, Norway

10:20 Committee Discussion and Review:

Committee Reviewer: Alan Hirsch, M.D.

12:00 Lunch

1:00 Meeting Open for Public Comments

2:00 Committee Discussion Continues

3:00 Break

4:30 Adjourn