Approvals In Brief
This article was originally published in Pharmaceutical Approvals Monthly
Merck’s Januvia becomes the first DPP-4 inhibitor to reach the market. FDA clears Novartis’ nucleoside analog Tyzeka (telbivudine) for treatment of adults with chronic hepatitis B; the new molecular entity will be priced at a premium to GSK’s Epivir HBV (lamivudine). AstraZeneca’s Seroquel (quetiapine) gains an indication for treatment of depressive episodes associated with bipolar disorder. GlaxoSmithKline’s extended-release heart failure therapy Coreg CR (carvedilol) gains approval
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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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