Schering-Plough gets US approval for pegylated interferon alfa product

Schering-Plough has won the race to bring a pegylated interferon alfaproduct to the US market. The company's PEG-Intron (peginterferon alfa-2b) has been approved by the US Food and Drug Administration as a once-weekly monotherapy for adults with chronic hepatitis C virus infection who have compensated liver disease and are interferon alfa-naive, and the product should be launched in February.

Roche, which is developing a rival product brand-named Pegasys (peginterferon alfa-2a), may not hear from the FDA regarding its application until May. Meanwhile, PEG-Intron has already been approved and launched in the European Union (Marketletter June 5, 2000), while Roche was due to file for Pegasys there at the end of last year.

Although interferon alfa is a mainstay of chronic HCV and is often used as a monotherapy, S-P has been focusing on the use of its non-pegylated version, Intron A, in combination with ICN Pharmaceuticals' Virazole (ribavirin), which improves response rates. The two drugs are bundled together and sold as Rebetron under an agreement forged between the two companies.