Food and Drug Administration
Center for Drug Evaluation and Research
Cardiovascular and Renal Drugs Advisory Committee
97th Meeting
July 19, 2002
Holiday Inn, 8120 Wisconsin Avenue, Bethesda, MD
AGENDA
8:00 Call to Order and Opening Remarks Jeffrey Borer, MD, Chair
Introduction of Committee
Conflict of Interest Statement Jayne E. Peterson, RPh, JD,
Acting Executive Secretary, FDA
8:15 NDA 21-188, VANLEVÔ (omapatrilat), Bristol-Myers Squibb Company, proposed for
the treatment of hypertension.
Sponsor’s Presentation
Introduction Anthony Waclawski, PhD
Director, Global Regulatory Sciences,
Pharmaceutical Research Institute,
Bristol-Myers Squibb Company
Clinical Efficacy Data Elliott Levy, MD
Vice President, Clinical Development,
Pharmaceutical Research Institute,
Bristol-Myers Squibb Company
Angioedema: Clinical Overview Allen Kaplan, MD
Professor, Department of Medicine,
Medical University of South Carolina,
Charleston, South Carolina
Clinical Safety Data Elliott Levy, MD
Benefit/Risk Considerations Charles H. Hennekens, MD
Professor of Medicine & Epidemiology/Public Health
University of Miami School of Medicine
Clinician’s Perspective Henry Black, MD
Chairman, Department of Preventative
Medicine, Professor of Internal Medicine,
Rush Medical College, Rush University
Chicago, Illinois
Conclusion Anthony Waclawski, PhD
Cardiovascular and Renal Drugs Advisory Committee
97th Meeting
July 19, 2002
Holiday Inn, 8120 Wisconsin Avenue, Bethesda, MD
AGENDA (cont.)
9:15 Committee Discussion and Review
Committee Reviewer: Steven Nissen, MD
10:00 Break
10:15 Open Public Hearing
10:45 Continuation of Committee Discussion and Review
12:00 Lunch
1:00 Continuation of Committee Discussion and Review
3:00 Adjourn
Meeting Guest (non-voting)
Thomas G. Pickering, MD, 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