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Gilead Seeks HBV Approval for Viread

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Gilead Sciences, Inc. has submitted a sNDA to the FDA and a Type II variation to the EMEA for marketing approval of Viread for the treatment of chronic hepatitis B in adults. Viread is currently approved in the U.S. and EU for the treatment of HIV as part of a combination antiretroviral therapy. The submissions include data from two Phase III trials, Studies 102 and 103, in patients chronically infected with the hepatitis B virus (HBV). These studies evaluate the safety, efficacy and tolera...

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