Schering-Plough Announces FDA Approval of Rebetol for Use in Treating Pediatric Hepatitis C

KENILWORTH, N.J. -- Schering-Plough Corporation today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval to Rebetol (ribavirin, USP) oral solution and capsules for use in the treatment of pediatric hepatitis C.

"Rebetol combination therapy with INTRON A represents the first and only therapy approved in the United States for treating hepatitis C in children," said Robert J. Spiegel, MD, senior vice president of medical affairs and chief medical officer, Schering-Plough Research Institute. "For more than a decade, Schering-Plough has been the leader in developing new treatments for chronic hepatitis C. We remain committed to developing innovative therapies to meet the needs of patients with hepatitis C and other serious diseases."

In the pediatric population, Rebetol is indicated for use in combination with INTRON A (interferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with alpha interferon. For these patients, individualized combination therapy is recommended, with Rebetol dosed according to patient body weight and INTRON A dosed according to patient size measured in body surface area. The recommended duration of therapy is 24 weeks for pediatric patients with genotype 2/3 virus and 48 weeks for pediatric patients with genotype 1 virus.

The New Drug Application (NDA) for REBETOL for pediatric use was submitted to FDA in January 2003 and received priority review. Priority review status is granted to drugs that, if approved, would address unmet medical needs and represent significant advances over existing treatments. It is estimated that less than 200,000 children in the United States are infected with the hepatitis C virus.

Schering-Plough also noted that FDA has granted orphan-drug designation to Rebetol for the treatment of chronic hepatitis C in pediatric patients.

Rebetol Oral Solution represents a new formulation of ribavirin, USP. Rebetol capsules are approved in the United States for use in combination therapy with INTRON A for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon or who have relapsed following alpha interferon therapy. Rebetol capsules also are indicated in combination with PEG-INTRON (peginterferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon and are at least 18 years of age.

Some 4 million Americans are infected with the hepatitis C virus (HCV) and approximately 70 percent of infected patients go on to develop chronic liver disease, according to the Centers for Disease Control and Prevention (CDC). Hepatitis C infection contributes to the deaths of an estimated 8,000 to 10,000 Americans each year and this toll is expected to triple by the year 2010, according to the CDC. The CDC has reported that HCV-associated end-stage liver disease is the most frequent indication for liver transplantation among adults. It is predicted that direct U.S. medical costs to treat HCV-related disease will exceed $13 billion for the years 2010 through 2019, according to a study published in the American Journal of Public Health.

Since the introduction of PEG-INTRON and Rebetol combination therapy in 2001, more than 250,000 hepatitis C patients worldwide have received this treatment, including 150,000 patients in the United States. Twenty-five percent of all U.S. patients currently treated with PEG-INTRON and Rebetol are enrolled in the company's Commitment to Care program, which provides medication and/or reimbursement assistance to eligible patients. The market value of assistance and treatment provided to hepatitis C patients through this program exceeded $100 million in 2002.

Schering-Plough's Be In Charge hepatitis C patient-support program has enrolled more than 55,000 U.S. patients to date, with more than 25,000 patients enrolling in 2002 alone. This U.S. program is designed to support patients treated with Schering-Plough hepatitis C products through the use of educational materials and telephone contact with personal nurse counselors skilled in the management of hepatitis C.

Source: Schering-Plough