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Novartis telbivudine Phase III HBV data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

novartis' hepatitis B agent telbivudine meets its primary endpoint of one-year response in the pivotal GLOBE trial, the firm reports July 28. The composite endpoint, "designed to assess if telbivudine was at least as effective as lamivudine [GlaxoSmithKline's Epivir], evaluated the combination of viral suppression…with either improved liver function…or loss of detectable hepatitis B e-antigen," Novartis says. The two-year, 1,350-patient trial is ongoing and includes both antigen positive and negative patients. "The one-year analysis of this trial will be the primary data used" in the NDA, which Novartis continues to project submitting by the end of 2005. Novartis believes that emerging Epivir resistance could be an advantage for telbivudine (1Pharmaceutical Approvals Monthly February 2005, p. 3)...

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