FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING
December 12, 2001
Holiday Inn –Bethesda, Maryland
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
9:00 a.m. FDA Presentation Louis Marzella, M.D., Ph.D.
Division of Clinical Trial Design and Analysis
Center for Biologics Evaluation and Research
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