WHO welcomes FDA approval of injectable Lenacapavir for HIV prevention

The World Health Organization (WHO) has welcomed the recent approval by the United States Food and Drug Administration (FDA) of injectable lenacapavir for HIV prevention. The regulatory milestone marks a significant advancement in global HIV prevention strategies and follows promising 2024 results from the PURPOSE 1 and PURPOSE 2 trials.

The trials demonstrated lenacapavir’s safety and efficacy across diverse populations and settings. Notably, the drug requires administration only twice a year, offering sustained protection and adding to the expanding array of HIV prevention options.

Currently, WHO recommends oral PrEP, the dapivirine vaginal ring, and long-acting injectable cabotegravir (CAB-LA) as approved methods for pre-exposure prophylaxis (PrEP). Lenacapavir’s discreet, long-acting injectable format may help overcome persistent barriers in HIV prevention, including the burden of daily pills, need for frequent clinic visits, and stigma.

“This regulatory milestone brings us one step closer to expanding access to an innovative HIV prevention option in lenacapavir,” said Dr Meg Doherty, Director of WHO’s Global HIV, Hepatitis and STI Programmes. “WHO plays a key role in supporting countries through guideline development, prequalification, and regulatory processes. We are working with partners and national authorities to ensure lenacapavir reaches people who need it most – quickly, safely and equitably.”

WHO guidelines for injectable lenacapavir are scheduled for release on July 14, 2025, during the International AIDS Conference in Kigali, sources said. 

The FDA approval also enables the WHO prequalification process, potentially speeding up national regulatory approvals following endorsement by a stringent regulatory authority (SRA) and procurement by global donor agencies such as the Global Fund. Simultaneously, WHO is collaborating with the European Medicines Agency (EMA) to support the Medicines 4 All (M4All) mechanism, which facilitates regulatory pathways in countries adopting lenacapavir. aa