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Home Industry News Schering-Plough announces label changes for Pegintron and Rebetol

Schering-Plough announces label changes for Pegintron and Rebetol

28th March 2008

Pharmaceutical company Schering-Plough has revealed details of newly approved label revisions for Pegintron (peginterferon alfa-2b) and Rebetol (ribavarin, USP).

Following a trial involving more than 4,900 subjects, which it said was the largest hepatitis C study in the US, weight-based dosing of Rebetol has been recommended, ranging from 800mg to 1,400mg daily.

In addition, the combination therapy is now advised for patients suffering from chronic hepatitis C genotype 2 or 3 as a shorter 24-week course.

According to Schering-Plough, the approval of such doses represents the first of ribavirin as a 1,400mg measurement, while it is also the widest dosing range for the drug when used in combination with peginterferon.

“Pegintron and weight-based ribavirin was significantly more effective than flat-dosed ribavirin, especially in genotype 1 patients and provided consistent efficacy across all weight groups,” said Ira M Jacobson, principal investigator in the study.

Earlier this month, Schering-Plough submitted an application with Centocor for the approval of Golimumab in Europe as a treatment for various types of arthritis.

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