Gilead Submits New Drug Application to U.S. Food and Drug Administration for Twice-Yearly Lenacapavir for HIV Prevention
Lenacapavir Named 2024 “Breakthrough of the Year” by Science Magazine Fost er City, Calif., December 19, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced the company completed New Drug Application (NDA) submissions to the U.S. Food and Drug Administration (FDA) seeking approval of an investigational use of lenacapavir — the company’s twice-yearly injectable HIV-1 capsid inhibitor — for the prevention of HIV as pre-exposure prophylaxis (PrEP). The submission is supported by data from the Phase
