FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING

DRAFT AGENDA

May 13, 2003

Holiday Inn, Two Montgomery Village Avenue, Gaithersburg, MD

NDA 21-567 and 21-568, Reyataz^™ (atazanavir sulfate) capsules and powder for oral use, Bristol-Myers Squibb Company, proposed for the treatment of HIV infection in combination with other antiretroviral agents

8:00 a.m. Call to Order Roy M. Gulick, M.D., M.P.H.

Chair, AVAC

Introduction of Committee

Conflict of Interest Statement Tara P. Turner, Pharm.D.

Executive Secretary, AVAC

8:15 a.m. Opening Remarks Debra B. Birnkrant, M.D. Director

Division of Antiviral Drug Products

FDA

8:30 a.m. Evaluation of QT Interval FDA Consultant

8:45 a.m. Sponsor Presentation Bristol-Myers Squibb Company

Introduction Elliott Sigal, M.D., Ph.D.

Sr. Vice President, Global Clinical

and Pharmaceutical Development

Clinical Development Program and Steven M. Schnittman, M.D.

Clinical Trial Results Vice President, Global Development

Cardiac Electrophysiology Evaluations John H. Lawrence, M.D.

Executive Director

Clinical Design and Evaluation

Characterization of Hyperbilirubinemia Michael Giordano, M.D.

Group Director

Clinical Design and Evaluation

Characterization of Lipid Profile Michael Giordano, M.D.

Group Director

Clinical Design and Evaluation

Overall Risk/Benefit and Conclusions Elliott Sigal, M.D., Ph.D.

9:45 a.m. Questions from the Committee

10:00 a.m. Break

10:15 a.m. FDA Presentation Kendall Marcus, M.D.

Medical Officer

Division of Antiviral Drug Products

Lisa Naeger, Ph.D.

Microbiology Reviewer

Division of Antiviral Drug Products

Tom Hammerstrom, Ph.D.

Statistical Reviewer

Division of Biometrics III

11:15 a.m. Questions from the Committee

12:00 p.m. Lunch

1:00 p.m. Open Public Hearing

2:00 p.m. Charge to the Committee/Questions for Discussion Debra B. Birnkrant, M.D.

5:00 p.m. Adjourn