FDA approves re-treatment with Hep C drugs

March 16, 2009

FDA Expands Use of Schering's Hepatitis C Drugs
While previously only approved for patients who had never taken any Hepatitis C drugs, Pegintron and Rebetol are now approved by the FDA for re-treatment.
Schering say FDA expands hepatitis drug labels
Associated Press, 03.11.09, 04:39 PM EST
The Food and Drug Administration expanded the label for Schering-Plough Corp.'s hepatitis C drugs Pegintron and Rebetol, allowing the company to market the drugs for patients who have not recovered from the disease after previous treatment. Schering-Plough (nyse: SGP - news - people ) said Wednesday that the FDA approved the drugs for the treatment of chronic hepatitis C in patients with compensated liver disease. They were already approved for use in "treatment-naive" patients, or those who had never taken any drugs for the liver disease.
The drugs are approved for use in patients 3 and older. The company said more than 100,000 people in the U.S. have received at least one unsuccessful treatment for hepatitis C. Sales of Pegintron totaled $914 million in 2008, and Schering-Plough reported $260 million in Rebetol revenue. Schering-Plough on Monday accepted a buyout offer from Merck and Co. (nyse: MRK - news - people ) worth $41.1 billion.
Copyright 2009 by Associated Press