Schering-Plough's PEG-Intron Approved in China for Treating Hepatitis B

Schering-Plough announced that PEG-Intron has been approved by the Chinese State Food and Drug Administration (SFDA)for the treatment of chronic hepatitis B, the most prevalent infectious disease in China, according to the company.

PEG-Intron (peginterferon alfa-2b) is administered once a week at an individualized dose according to a patient's weight and is the only pegylated interferon indicated in China for treating hepatitis B in 24 weeks.

The approval is based in part on a multicenter clinical trial in e-antigen-positive chronic hepatitis B patients in China showing that PEG-Intron achieved a sustained response with 24 weeks of therapy when used as a first-line treatment. The drug has been available in China since 2004 for the treatment of chronic hepatitis C.

"Schering-Plough is pleased to offer this effective new treatment option for Chinese patients with chronic hepatitis B, a major public health problem in China," Robert Spiegel, chief medical officer and senior vice president of Schering-Plough Research Institute, said. "We applaud the SFDA and Chinese healthcare professionals for their ongoing efforts in fighting hepatitis B, and we are committed to continuing our work with them and to educating patients on the importance of effective antiviral treatment."