Schering-Plough Corp. said Tuesday that it is seeking U.S. regulatory approval to sell its combination hepatitis C therapy to a wider group of patients, including those who have not been treated with standard hepatitis drugs.
The news follows an announcement last month that the combination of drugs developed by Schering-Plough and Costa Mesa-based ICN Pharmaceuticals Inc. offers significant benefits to previously untreated patients.
Currently, the combination is approved only for patients who have suffered a relapse after therapy.
Only about 1.5% of patients eligible for therapy are receiving it, because current drugs often don’t benefit patients, said Robert Consalvo, a spokesman for Madison, N.J.-based Schering-Plough.
Combination therapy, which has been shown to work better than single drug therapy, may encourage more patients to seek treatment, he said.
Schering-Plough shares rose $1.63 to close at $88.50, and ICN’s rose 88 cents to close at $43.88. Both trade on the New York Stock Exchange.
The company asked the Food and Drug Administration to give the application a “priority review,” which generally means the review is completed within six months.
Schering-Plough sells the combination, made up of its Intron-A and ICN’s Rebetol, under the brand name Rebetron.
Experts estimate that almost 4 million Americans are infected with hepatitis C.