FDA grants traditional approval for Gilead's HIV medications Truvada and Viread

By Lisa Kerner

Erie, Pa., March 8 - Gilead Sciences, Inc. said the Food and Drug Administration has granted traditional approval status to its once-daily antiretroviral Viread (tenofovir disoproxil fumarate) and its fixed-dose product Truvada (emtricitabine and tenofovir disoproxil fumarate), which combines the company's two antiretrovirals Emtriva (emtricitabine) and Viread in a single daily tablet, for the treatment of HIV-1 infection.

The traditional approval status was granted following the FDA's review of 48-week data from Study 934, the second confirmatory pivotal study for Viread, according to a company news release.

Study 934, a phase 3 open-label trial, compared a once-daily regimen of Viread, Emtriva and efavirenz to twice-daily Combivir (lamivudine/zidovudine) and once-daily efavirenz in treatment-naive patients.

Gilead said 84% of patients in the Viread/Emtriva group achieved and maintained HIV RNA less than 400 copies/mL through week 48 compared to 73% of patients in the Combivir group. The company attributes the difference to the higher number of discontinuations in the Combivir group due to adverse events, lost to follow-up, patient withdrawal, noncompliance and protocol violation.

Additionally, 80% and 70% of patients in the Viread/Emtriva group and the Combivir group, respectively, achieved and maintained HIV RNA less than 50 copies/mL.

"In the United States, Truvada is now the most-prescribed antiretroviral of its class and its use is quickly growing in the European Union, where it was more recently made available," executive vice president, commercial operations Kevin Young said in the release.

"We look forward to continuing to generate and share important data from ongoing clinical studies to help further define the profile of our products for the medical community."

Gilead and Bristol-Myers Squibb have established a U.S. joint venture to produce a once-daily fixed-dose product containing Truvada and efavirenz and expect to file a New Drug Application with the FDA in the second quarter of this year, the release stated.

Gilead is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company is based in Foster City, Calif.

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