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news.Schering-Plough has announced that the FDA has granted marketing approval to Pegintron and Rebetol combination therapy for use in previously untreated patients three years of age and older with chronic hepatitis C.
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According to the company, this represents the first and only approved Pegintron in combination with Rebetol for treating pediatric hepatitis C. Rebetol is available both as capsules and in an oral solution formulation specifically available for pediatric use.
The approval of Pegintron for the pediatric indication is based on the results of a clinical trial in 107 previously untreated patients three to 17 years of age with chronic hepatitis C and compensated liver disease.
In the pediatric population, the recommended dose of Pegintron, based on body surface area, is 60mcg/m2/week subcutaneously in combination with 15mg/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, the company said.
Robert Spiegel, chief medical officer of Schering-Plough Research Institute, said: “With the FDA approval of Pegintron combination therapy for this new indication, US physicians now have access to the current standard of care for hepatitis C for use in treating their pediatric patients.
“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.”