By Lisa Seachrist
WASHINGTON — Following the advice of an advisory panel that met in May, FDA granted marketing approval to Schering-Plough Corp. for its hepatitis C (HCV) combination therapy, Rebetron.
The therapy is a combination of Schering-Plough's Intron A (recombinant alpha interferon) and ICN Pharmaceutical Inc.'s antiviral Rebetol (ribavirin) for the treatment of patients with compensated liver disease who have relapsed following alpha interferon therapy.
Rebetron will consist of three-times-weekly Intron A injections packaged with twice-daily Rebetol capsules. The Madison, N.J.-based company intends to have the combination therapy available June 8.
Intron A already was approved by FDA for HCV. However, the treatment is only effective in 20 percent of patients. Thirty percent of the 4 million Americans infected with HCV will develop a chronic form of the infection that leaves them susceptible to cirrhosis of the liver and liver cancer.
In 1995, FDA refused to approve ribavirin as a monotherapy for HCV. At that time, Schering-Plough licensed the drug from Costa Mesa, Calif.-based ICN to study it in combination with Intron A. Ribavirin, a synthetic nucleoside with antiviral activity, is currently approved as an inhaled treatment for respiratory syncytial virus under the name Virazole.
Rebetron joins Intron A and Thousand Oaks, Calif.-based Amgen Inc.'s Infergen (recombinant type 1 interferon) as marketed treatments for HCV. *