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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
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