The World Health Organization (WHO) has welcomed the landmark approval by the U.S. Food and Drug Administration (FDA) of injectable lenacapavir for HIV prevention, marking what experts call a “transformational moment” in the global fight against HIV.
Lenacapavir, administered only twice a year, was found to be highly effective and safe in the PURPOSE 1 and 2 trials, which concluded in 2024.
The long-acting injectable offers sustained protection against HIV, making it the latest tool in the growing arsenal of pre-exposure prophylaxis (PrEP) methods.
“This regulatory milestone brings us one step closer to expanding access to an innovative HIV prevention option in lenacapavir,” said Dr. Meg Doherty, WHO’s Director for Global HIV, Hepatitis and STI Programmes.
“We are working with national authorities to ensure lenacapavir reaches those who need it most—quickly, safely, and equitably.”
Currently, WHO recommends oral PrEP, the dapivirine vaginal ring, and the long-acting injectable cabotegravir (CAB-LA) as approved HIV prevention tools.
Lenacapavir’s biannual injection schedule, coupled with its discreet and long-acting nature, is expected to overcome barriers such as daily pill fatigue, stigma, and the need for frequent clinic visits.
WHO is set to release formal guidelines on lenacapavir use on July 14, 2025, during the International AIDS Conference in Kigali, Rwanda.
FDA approval is a crucial step toward WHO prequalification, a process that can accelerate global uptake by smoothing regulatory approvals in low- and middle-income countries.
Prequalification also enables bulk procurement through international funding bodies like the Global Fund to Fight AIDS, Tuberculosis and Malaria.
In tandem, WHO is working with the European Medicines Agency (EMA) through the Medicines 4 All (M4All) initiative to further streamline regulatory pathways and ensure affordable, timely access in countries where the need is greatest.
With over 1.3 million new HIV infections globally in 2023 alone, public health experts say the addition of lenacapavir to the prevention toolkit could be a game-changer—especially for vulnerable populations, including young women and men who have sex with men, in high-burden regions like sub-Saharan Africa.
