Schering-Plough Corporation 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, 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.