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FDA Approves Peginterferon-Ribavirin for Patients Aged 3 and Older

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 of patients with hepatitis C."

The approval of PEGINTRON for the pediatric indication is based on the results of a clinical trial in 107 previously untreated patients 3 to 17 years of age with chronic hepatitis C and compensated liver disease. In the study, patients infected with HCV genotype 1 or 4 and those with HCV genotype 3 with HCV RNA greater than 600,000 IU/mL (high viral load [HVL]) were assigned 48 weeks of therapy, while those infected with HCV genotype 2 or 3 with HCV RNA less than 600,000 IU/mL (low viral load [LVL]) received 24 weeks of therapy. Of the patients with HCV genotype 1, 4 or 3 HVL who were assigned to 48 weeks of treatment, 55 percent achieved SVR. As with adult patients, SVR in pediatric patients with HCV genotype 2 or 3 LVL was much higher than in those with genotype 1; the SVR rate was 96 percent in children with HCV genotype 2 or 3 LVL.

In the pediatric population, the recommended dose of PEGINTRON, based on body surface area, is 60 mcg/m2/week subcutaneously in combination with 15 mg/kg/day of REBETOL, based on body weight, orally in two divided doses. The treatment duration for patients with HCV genotype 1 is 48 weeks and for patients with HCV genotype 2 or 3 it is 24 weeks. Patients receiving PEGINTRON combination therapy (excluding those with HCV genotype 2 or 3) should be discontinued from therapy at week 12 if their HCV RNA dropped less than 2 log10 compared to pretreatment or at 24 weeks if they have detectable HCV RNA at treatment week 24.

During the course of therapy lasting up to 48 weeks in patients 3 to 17 years of age, weight loss and growth inhibition were common. Some children who experienced growth inhibition during therapy still had inhibited growth velocity 6 months following the end of treatment. Most common adverse reactions (more than 25 percent) observed in these studies were pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema and vomiting. Three percent were treated for clinical hypothyroidism.

Dose modifications were required in 25 percent of patients, most commonly for anemia, neutropenia and weight loss. Therapy was discontinued prematurely in two percent of the patients.

About Hepatitis C
Hepatitis C is a serious and potentially life-threatening disease. It is the most common blood-borne infection in America and the most common form of liver disease, affecting nearly 5 million people in the United States alone. It is the leading cause of cirrhosis and liver cancer, and the number one reason for liver transplants in the United States.

In the United States, PEGINTRON is indicated for use in combination with ribavirin in patients 3 years of age or older, and as monotherapy in patients 18 years of age and older, for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha.

Source: Schering-Plough Corporation

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