US approval for S-P's Peg-Intron in combo with Rebetol for hep C

The US Food and Drug Administration has approved Schering-Plough'sPEG-Intron (peginterferon alfa-2b) powder for injection for use in combination therapy with Rebetol (ribavirin) capsules for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.

This treatment regimen is the first and only pegylated interferon-based combination therapy approved in the USA, the company points out. PEG-Intron was granted marketing approval by the FDA at the beginning of the year (Marketletter January 29) as a once-weekly monotherapy for this indication. Rebetol was approved in July as a separately-marketed product for use alone, rather than in a kit combination with Intron A (recombinant interferon alfa-2b: Marketletter August 6).