FDA Lets ICN and Schering Expand Hepatitis C Therapy

Schering-Plough Corp. and ICN Pharmaceuticals Inc. won regulatory approval Wednesday to sell their combination hepatitis C treatment to a wider group of patients.

The Food and Drug Administration approved the combination therapy known as Rebetron for use in patients who haven’t been treated already with standard hepatitis-fighting drugs.

The wider use should boost sales for Schering-Plough, the eighth biggest U.S. drug maker, and Costa Mesa-based ICN, Eastern Europe’s largest drug maker.

The combination of injections of Schering-Plough’s Intron-A drug and an oral drug called Ribavirin, developed by ICN and licensed to Schering-Plough, had been approved previously for patients after they suffered a relapse.

An estimated 4 million Americans carry the silent hepatitis C virus, although few are aware of their infection. In about 20% of all infected people it triggers severe liver damage including cirrhosis and even liver cancer. Others may lead a full life with few problems.

The FDA had approved the treatment in May for patients who suffered a relapse after therapy. A month later, Schering-Plough said the combination offered significant benefits to previously untreated patients, and that it had asked the FDA to give “priority review” to its application to expand the therapy to a wider group.

Schering-Plough’s Intron-A had sales of $598 million last year. ICN’s compound was already sold under the brand name Virazole for treatment of respiratory infections.