New HIV Prevention Drug Approved by FDA After Trial Gains

The World Health Organization (WHO) welcomes the approval by the United States Food and Drug Administration (FDA) of injectable lenacapavir for HIV prevention.

This milestone follows promising 2024 results from the PURPOSE 1 and PURPOSE 2 trials, which demonstrated the safety and efficacy of lenacapavir across diverse populations and settings. Administered just twice a year, lenacapavir offers sustained protection and adds to the growing range of HIV prevention options.

WHO currently recommends oral PrEP, the dapivirine vaginal ring, and long-acting injectable cabotegravir (CAB-LA) as options for HIV pre-exposure prophylaxis (PrEP). Lenacapavir’s discreet, long-acting formulation may help overcome key barriers such as daily pill burden, frequent clinic visits, and stigma associated with HIV prevention.

“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 will be released on 14 July 2025, during the International AIDS Conference in Kigali.

FDA approval also paves the way for WHO prequalification, which can accelerate national regulatory approvals following endorsement by a stringent regulatory authority (SRA) and procurement by donor agencies like the the Global Fund. In parallel, WHO is working with the European Medicines Agency (EMA) to support the Medicines 4 All (M4All) mechanism, which facilitates regulatory pathways in countries adopting lenacapavir.