November 13, 2002

MEMORANDUM

FROM William Tauber M.D., and Louis Marzella M.D., Ph.D.,

Clinical Reviewers, Infectious Diseases and Immunology

Branch

TO Karen Weiss M.D., Director, Division of Clinical Trial Design and Analysis, Office of Therapeutics Research and Review, CBER

TOPIC Biologic License Application

BLA 125061-0

PEGASYS^® (Peginterferon alfa-2a, Ro 25-8310) in Combination with COPEGUS ^® (Ribavirin, Ro 20-9963) for the treatment of hepatitis C

ATTACHMENT Briefing Package

Antiviral Drugs Advisory Committee

November 14, 2002