U.S. Food and Drug Administration official announcements

Gilead's Lenacapavir Named 2024 Breakthrough for HIV Prevention, Aiming to Reach 2 Million

Dec 17, 2024, 08:38 AM

Lenacapavir, a new injectable drug developed by Gilead Sciences, has been named the 2024 Breakthrough of the Year by the scientific journal Science. Administered every six months, the drug has demonstrated remarkable success in preventing HIV infection, with clinical trials showing 100% effectiveness in preventing HIV among women in Africa and 99.9% effectiveness among diverse gender groups globally. Lenacapavir targets the HIV capsid, a protein that protects the virus's genetic material, and its mechanism could potentially influence treatments for other viral diseases. The Global Fund to Fight AIDS, Tuberculosis and Malaria, along with the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), have announced a coordinated effort to provide affordable access to lenacapavir for HIV pre-exposure prophylaxis (PrEP) to at least 2 million people over three years in countries they support, contingent upon regulatory approvals from the U.S. Food and Drug Administration, national pharmaceutical regulators, and a recommendation from the World Health Organization (WHO).