Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Cardiovascular and Renal Drugs Advisory Committee
98th Meeting
January 6, 2003
Holiday Inn, 8777 Georgia Avenue, Silver Spring, MD
AGENDA
8:30 Call to Order and Opening Remarks Jeffrey Borer, M.D., Chair
Introduction of Committee
Conflict of Interest Statement Jayne E. Peterson, R.Ph., J.D., Acting Executive Secretary, FDA
______________________________________________________________________
sNDA 20-386/S-032 Cozaarâ (losartan potassium) Tablets, Merck and Co.
Proposed for the reduction in the risk of cardiovascular morbidity and mortality as
measured by the combined incidence of cardiovascular death, stroke and myocardial
infarction in hypertensive patients with left ventricular hypertrophy.
8: 45 Sponsor Presentation
Introduction
Jeffrey R. Tucker, M.D.
Director, Regulatory Affairs
Merck Research Laboratories
The LIFE Study: Background, Rationale and Results
Jonathan M. Edelmann, M.D.
Senior Director, Clinical Development
Merck – U.S. Human Health Division
Review of the Evidence and Conclusions
William F. Keane, M.D.
Vice President, Clinical Development
Merck – U.S. Human Health Division
10:15 Break
10:30 FDA Presentation
Ethnic Subgroup Analysis from the LIFE Study
John Lawrence, Ph.D.
Mathematical Statistician, FDA
Cardiovascular and Renal Drugs Advisory Committee
98th Meeting
January 6, 2003
AGENDA (cont.)
11:00 Committee Discussion and Review
Committee Reviewer: Thomas Fleming, Ph.D.
12:00 Lunch
1:00 Open Public Hearing
2:00 Continuation of Committee Discussion and Review
3:00 Break
3:15 Continuation of Committee Discussion and Review
5:00 Estimated Time of Adjournment
SGE Consultant (voting)
Thomas G. Pickering, M.D., DPhil
Professor of Medicine
Director, Integrative and Behavioral Cardiovascular Health Program
and Hypertension Section
Michael and Zena A. Wiener Cardiovascular Institute
Mount Sinai School of Medicine
One Gustave L. Levy Place
New York, New York 10029-6574
Acting Industry Representative (non-voting)
John Neylan, M.D.
Vice President, Clinical Research and Development
Wyeth Research
500 Ariola Road
Collegeville, Pennsylvania 19426