Schering-Plough Submits Supplemental NDA for Use of REBETRON(TM) Combination Therapy in Treatment-Naive Hepatitis C Patients
MADISON, N.J., June 16 /PRNewswire/ — Schering-Plough Corporation (NYSE: SGP) today announced that it has submitted a supplemental New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for REBETRON(TM) Combination Therapy containing REBETOL(R) (ribavirin, USP) Capsules and INTRON(R) A (interferon alfa-2b, recombinant) Injection for the treatment of chronic Hepatitis C in patients with compensated liver disease previously untreated with alpha interferon therapy (treatment-nanve patients). The company has requested priority review status for the supplemental NDA.
The FDA on June 3 granted marketing approval for REBETRON combination therapy for the treatment of chronic Hepatitis C in patients who have relapsed following alpha interferon therapy. Schering-Plough has submitted a Marketing Authorization Application for the combination therapy to the European Agency for the Evaluation of Medicinal Products (EMEA) for the treatment of relapse Hepatitis C patients. An identical application has been submitted to the EMEA under which oral ribavirin capsules, if approved, are planned to be marketed by ICN Pharmaceuticals under the brand name VIRAZOLE(R).
REBETOL is an oral formulation of ribavirin, a synthetic nucleoside analog with broad-spectrum antiviral activity. Schering-Plough has exclusive rights to market oral ribavirin for Hepatitis C in all major world markets through a licensing agreement with ICN Pharmaceuticals, Inc. (NYSE: ICN) of Costa Mesa, Calif., except in the European Union (EU), where both companies have the right to market oral ribavirin for Hepatitis C.
INTRON A is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects. Schering-Plough markets INTRON A, the world’s largest-selling alpha interferon, for 16 major antiviral and anticancer indications worldwide.
Some 4 million Americans are chronically infected with the Hepatitis C virus, according to the Centers for Disease Control and Prevention (CDCP). The CDCP has estimated that 20-50 percent of chronically infected Hepatitis C patients will develop liver cirrhosis, and 20-30 percent of those will go on to develop liver cancer or liver failure requiring liver transplant. Hepatitis C infection contributes to the deaths of 8,000 to 10,000 Americans each year. This toll is expected to triple by the year 2010 and exceed the number of annual deaths due to AIDS, according to the CDCP. The American Liver Foundation has reported that liver failure due to Hepatitis C infection is the leading cause of liver transplants in the United States.
Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and health care products worldwide.
SOURCE Schering-Plough Corporation