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Gilead Emtriva approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Gilead Sciences' Emtriva (emtricitabine, formerly Coviracil) clears FDA July 2 as the agency's third new molecular entity approval for HIV in 2003. The once-daily nucleoside reverse transcriptase inhibitor is indicated for combination use with other antiretroviral agents for the treatment of HIV-1 infection in adults; labeling adds that in treatment-experienced patients, Emtriva can be used when HIV strains are expected to be susceptible based on genotypic/phenotypic testing. Gilead, which gained Emtriva via its January acquisition of Triangle, hopes to launch a fixed-dose combo of Emtriva and its nucleotide reverse transcriptase inhibitor Viread (tenofovir) in early 2005. Gilead also plans to initiate a study comparing a regimen of Emtriva, Viread and efavirenz to GSK's Combivir and efavirenz by year-en
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