Truvada Pre-Exposure Prophylaxis Data Have FDA Looking Ahead To REMS
This article was originally published in The Pink Sheet Daily
Executive Summary
Seemingly comfortable with the clinical data supporting a PrEP indication for the emtricitabine/tenofovir combination, FDA will ask its Antiviral Drugs Advisory Committee for input on Gilead’s proposed REMS, which does not include prescribing restrictions. FDA will ask the May 10 panel to vote whether the risk/benefit profile is acceptable in various subgroups.