The U.S. Food and Drug Administration (FDA) has granted the Schering-Plough Corporation six-month priority review status to the hepatitis C drug Rebetol (ribavirin) for use in children.
In January, Schering asked the FDA to approve the use of Rebetol in combination with its interferon alfa drug Intron A for the treatment of chronic hepatitis C in children three years of age and older.
Priority review status assumes that Rebetol would address unmet medical needs and represent a significant advance over existing treatments. While it is estimated that less than 200,000 children in the United States are infected with the hepatitis C virus, new infections in children continue to occur.
"FDA approval of Rebetol for use with Intron would represent the first and only therapy approved in the United States for treating hepatitis C in the pediatric population," said Dr. Robert J. Spiegel, a senior vice president at Schering-Plough Research Institute.
Other sources: Schering-Plough Corporation