Priority review for PrEP use of Truvada
This article was originally published in Scrip
Executive Summary
The US FDA has granted priority review status to Gilead's supplemental NDA for its combination antiretroviral Truvada (emtricitabine/tenofovir disoproxil fumarate) for use in preventing HIV infection. A PDUFA date is now set for 15 June, following discussion of the application by the agency's antiviral drugs advisory committee.