Wraps Template

November 14, 2001

Advisors and Consultants Staff

Food and Drug Administration

Center for Drug Evaluation and Research

Office of Regulatory Management

HFD-21, Room 1093

5630 Fishers Lane

Rockville, MD 20852-1734

SUBJECT: MATERIAL FOR THE ANTIVIRAL ADVISORY COMMITTEE MEETING DECEMBER 12, 2001

Dear Sir/Madam:

In response to the Agency letter dated October 30, 2001, Schering is providing for distribution to the Antiviral Advisory Committee 35 copies of the publications based on the results of the hepatitis pivotal clinical trial programs for REBETRON^TM, PEG-INTRON^TM and PEG-INTRON^TM/REBETOLÒ . The publications included are:

Rebetron

Davis GL, et al. Interferon alfa-2b alone or in combination with ribavirin for the treatment of relapse of chronic hepatitis C. N Engl J Med 1998;339:1493-1499

McHutchison JG, et al. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. N Engl J Med 1998;339:1485-1492

Poynard T, et al. Randomised trial of interferon a 2b plus ribavirin for 48 weeks of for 24 weeks versus interferon a 2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus. Lancet 1998; 352:1426-1432

PEG-Intron

Lindsay KL, et al. A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa 2b as initial treatment for chronic hepatitis C. Hepatology 2001; 34:395-403

PEG-Intron/Rebetol

Manns MP, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001; 358:958-965

As the material is copyrighted by the journal in which it was published, it is not being provided electronically.

Please contact Ms. Rachael Steiner (908-740-2565) or Dr. Penny Giles (908-740-2340) for additional information.

Sincerely,

Joseph F. Lamendola, Ph.D.
Vice President
U.S. Regulatory Affairs

RAS/eq