FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC)

IMMUNOSUPPRESSIVE DRUGS SUBCOMMITTEE MEETING

AGENDA

January 24, 2002

Gaithersburg Holiday Inn

Two Montgomery Village Avenue

Gaithersburg, MD 20879

NDA 21-083 Rapamune® (sirolimus) Oral Solution – Cyclosporine Withdrawal Maintenance Regimen

8:30 a.m. Call to Order and Opening Remarks Janet A. Englund, M.D.

Subcommittee Chair

Introduction of Subcommittee

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

Executive Secretary, AVAC

8:40 a.m. FDA Introductory Remarks Renata Albrecht, M.D.

Acting Director

Division of Special Pathogen

and Immunologic Drug Products, FDA

8:45 a.m. Sponsor Presentation Wyeth-Ayerst Research

Introduction Randall B. Brenner, M.S.

Senior Manager

Worldwide Regulatory Affairs

Overview John F. Neylan, M.D.

Design of Clinical Studies Vice President

Efficacy Review Transplantation Immunology,

Safety Review Clinical Research and Development

Pharmacokinetics James Zimmerman, Ph.D.

Concentration-Controlled Trials Senior Director

Therapeutic Drug Monitoring Clinical Pharmacokinetics,

Clinical Research and Development

Concluding Remarks John F. Neylan, M.D.

10:45 a.m. Break

11:00 a.m. FDA Presentation Rosemary Tiernan, M.D., M.P.H.

Medical Officer

Division of Special Pathogen

and Immunologic Drug Products, FDA

12:00 p.m. Lunch

1:00 p.m. Open Public Hearing

Alan Wilkinson, M.D., F.R.C.P.

Director, Kidney and Pancreas Transplantation

Professor of Medicine

UCLA

2:00 p.m. Charge to the Subcommittee Renata Albrecht, M.D.

2:10 p.m. Subcommittee Discussion and Vote

5:00 p.m. Adjourn