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February 15, 2012

FDA Gives Priority Review of Truvada as PrEP

The U.S. Food and Drug Administration (FDA) has accepted Gilead Sciences’ application to give priority review of Truvada (emtricitabine and tenofovir) as pre-exposure prophylaxis (PrEP), according to a Gilead statement. This PrEP is when an HIV-negative person takes a daily dose of Truvada as a means to lower the chance of contracting the virus during sex. The FDA grants fast-track appraisal to drug applicants that demonstrate major advances in treatment or provide a treatment where no adequate or current therapy exists. Approval of the supplemental New Drug Application (sNDA) will be discussed at the FDA Antiviral Drugs Advisory Committee in May. The target review date is June 15.

To read the Gilead statement, click here.

Search: U.S. Food and Drug Administration, FDA, Gilead Sciences, Truvada, pre-exposure prophylaxis, PrEP, supplemental New Drug Application, sNDA, Antiviral Drugs Advisory Committee


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