Schering-Plough wins FDA approval for expanded indication of hepatitis therapy

Schering-Plough has received the FDA approval for new labeling of Pegintron and Rebetol combination therapy for treating chronic hepatitis C in patients three years of age and older with compensated liver disease.

With approval of this expanded indication, Pegintron and Rebetol is said to be the first and only pegylated interferon combination therapy approved in the US that is not restricted to treatment-naive patients.

The approval of Pegintron for the expanded indication is based on the results of one of the clinical studies in the EPIC3 program, a non-comparative trial in which 2,293 adult patients with moderate-to-severe fibrosis or cirrhosis who failed previous treatment with combination alpha interferon/ribavirin were retreated with Pegintron (1.5mcg/kg once weekly) in combination with weight-adjusted Rebetol (800-1,400mg daily).

Robert Spiegel, chief medical officer of Schering-Plough Research Institute, said: With the FDA approval of Pegintron and Rebetol combination therapy for this new indication, US physicians now have a treatment option that offers a second chance for success to certain patients who failed prior therapy.

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.