Gilead, US FDA Ponder Innovative Designs For Descovy HIV Prevention Study In Women
Advisory committee sent a clear message that pre-exposure prophylaxis studies are needed in cisgender women, but what those studies might look like, and whether the agency can exercise its statutory authorities to ensure they are conducted, is less clear.
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US FDA's advisory committee review of Gilead’s Descovy for pre-exposure prophylaxis of HIV wasn’t exactly free of controversy. But the meeting sure went more smoothly than the first PrEP review seven years ago.
Gilead and the FDA failed women by letting PrEP application get this far without clinical efficacy data in non-transgendered females, panel members say in close vote against a broad indication; panelists urge the agency to mandate such studies regardless of the breadth of the HIV pre-exposure prophylaxis indication ultimately granted to the Truvada successor.