Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Cardiovascular and Renal Drugs Advisory Committee
98th Meeting
January 7, 2003
Holiday Inn, 8777 Georgia Avenue, Silver Spring, MD
AGENDA
8:00 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 20-297/S-009, Coregâ (carvedilol), GlaxoSmithKline
Proposed to reduce mortality and the risk of infarction in clinically stable patients who
have survived the acute phase of a myocardial infarction and have a left ventricular
ejection fraction £ 40%.
8:15 Sponsor Presentation
Introduction
Clare Kahn, Ph.D.
Vice President, U.S. Reg. Affairs
Cardiovascular, Urogenital &
Metabolic Products, GlaxoSmithKline
Background to the CAPRICORN Trial
Mary Ann Lukas, M.D.
Senior Clinical Director, GSK
CAPRICORN Trial
Primary Endpoints Henry Dargie, M.D., Univ. of Glasgow
Principal Investigator, CAPRICORN
Why are We Here? Milton Packer, M.D., Columbia Univ.
Planning Committee, CAPRICORN
Principal Investigator, COPERNICUS
CAPRICORN Trial Henry Dargie, M.D.
Effect on Non-Fatal Events
Safety and Concluding Remarks Milton Packer, M.D.
Cardiovascular and Renal Drugs Advisory Committee
98th Meeting
January 7, 2003
AGENDA (cont.)
9:30 Committee Discussion and Review
Committee Reviewer: Marc Pfeffer, M.D., Ph.D.
10:30 Break
10:45 Continuation of Committee Discussion and Review
12:00 Lunch
1:00 Open Public Hearing
2:00 Continuation of Committee Discussion and Review
3:15 Break
3:30 Continuation of Committee Discussion and Review
4:30 Estimated Time of Adjournment
SGE Consultants (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
Marc Pfeffer, M.D., Ph.D.
Professor of Medicine, Harvard Medical School
Senior Physician, Brigham & Women’s Hospital
Cardiovascular Division
75 Francis Street
Boston, Massachusetts, 02115
Acting Industry Representative (non-voting)
John F. Neylan, M.D.
Vice President, Clinical Research and Development
Wyeth Research
500 Ariola Road
Collegeville, Pennsylvania 19426