FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

Topic: An update on the approval of BLA 103949/5002, PEG-Intron™ (peginterferon alfa-2b) Powder for Injection, indicated for use alone or in combination with Rebetol (ribavirin, USP) for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.

8:15 a.m. Call to Order Roy M. Gulick, M.D., M.P.H.

Introduction of Committee

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

Executive Secretary, AVAC

8:30 a.m. Sponsor Presentation Schering Corporation

Introduction Dr. P. Giles

Director, Regulatory Affairs

Advances in the Treatment of Dr. J. Albrecht

Chronic Hepatitis C Vice President, Clinical Research

Risk:Benefit Decisions in Treating Dr. J. McHutchinson

Patients with Chronic Hepatitis C Medical Director, Liver Transplantation

Scripps Clinic

9:00 a.m. FDA Presentation Louis Marzella, M.D., Ph.D.

Medical Officer

Division of Clinical Trial Design and Analysis

Center for Biologics Evaluation and Research

FDA

9:30 a.m. Questions to Presenters

10:00 a.m. Open Public Hearing

Brian Klein – Hepatitis C Advocacy and Action Coalition (HAAC)

Jules Levin – National AIDS Treatment Advocacy Project (NATAP)

Kathleen Schwarz, M.D. - Chief, Pediatric Gastroenterology and Nutrition

Johns Hopkins Medical Center

11:00 a.m. Committee Discussion

12:15 p.m. Adjourn