GSK Seeks MHLW Approval For Hepsera As Single Agent Therapy
This article was originally published in PharmAsia News
Executive Summary
GlaxoSmithKline has filed for approval of Hepsera (adefovir pivoxil) as a single agent treatment with Japan's Ministry of Health, Labor and Welfare. Hepsera is currently approved in Japan in combination with Zefix to treat lamivudine-resistant chronic hepatitis B and cirrhosis hepatitis B. However, outside of Japan, Hepsera is also approved as a single agent to treat the diseases. American Association for the Study of Liver Diseases guidelines lists Hepsera as the top option for treating hepatitis B and cirrhosis hepatitis B. (Click here for more - Japanese language