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Showing posts from June 19, 2025

FDA approves injectable lenacapavir for HIV prevention.

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...