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Gilead Emtriva hep B data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Preliminary results of Gilead's Phase III hepatitis B study for Emtriva (emtricitabine) show a 62% improvement in the primary endpoint of liver histology, compared to 25% for placebo (p<0.001). Data from the 48-week, 248-patient study will be presented at a major medical meeting in 2004. Gilead hopes to have guidance from FDA for a regulatory plan by the middle of 2004. The firm previously indicated that it expects to submit a hepatitis B NDA for the nucleoside reverse transcriptase inhibitor in late 2004. Roche also is planning a 2004 hepatitis B submission for its peg-interferon product Pegasys (1Pharmaceutical Approvals Monthly Nov. 1, 2003, In Brief)...
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