Schering-Plough Announces FDA Approval of PEGINTRON(TM) and REBETOL(R) Combination Therapy for Treating Pediatric H...( First and only approved peginterferon...),Health

First and only approved peginterferon in combination with ribavirin for previously untreated children with chronic hepatitis C addresses unmet medical need

KENILWORTH, N.J., Dec. 12 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval to PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination therapy for use in previously untreated patients 3 years of age and older with chronic hepatitis C. This represents the first and only approved peginterferon in combination with ribavirin for treating pediatric hepatitis C. It is estimated that approximately 130,000 children in the United States are infected with the hepatitis C virus (HCV). The most common mode of HCV infection for pediatric patients today is maternal-infant transmission.

The only previously approved therapy in the United States for treating pediatric hepatitis C is Schering-Plough's conventional interferon INTRON(R) A (Interferon alfa-2b, recombinant) in combination with REBETOL. REBETOL is available both as capsules and in an oral solution formulation specifically available for pediatric use.

"With the FDA approval of PEGINTRON combination therapy for this new indication, U.S. physicians now have access to the current standard of care for hepatitis C for use in treating their pediatric patients. Thankfully, the number of children with hepatitis C is small, although this chronic infection over time can lead to serious liver disease," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "This approval further underscores Schering-Plough's leadership and long-term commitment to developing new treatment options and innovative therapies to meet the needs
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