Posted by Michael Wonder on 18 Feb 2025
US FDA accepts Gilead’s new drug applications for twice yearly lenacapavir for HIV prevention under priority review
18 February 2025 - FDA to review applications under priority review, with a PDUFA date of 19 June 2025.
Gilead Sciences today announced that the US FDA has accepted its new drug application submissions for lenacapavir—the company’s twice yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis.
