FDA Approval of Injectable Lenacapavir Marks Progress for HIV Prevention

The FDA’s approval of injectable lenacapavir marks a significant advancement in HIV prevention, offering a twice-yearly, long-acting option that addresses key barriers like daily pill burden and stigma. Backed by strong safety and efficacy data from recent trials, lenacapavir complements existing prevention tools such as oral PrEP and long-acting cabotegravir.

 

The World Health Organization (WHO) applauds this milestone and is preparing guidelines to support global access, emphasizing rapid, equitable distribution. With FDA approval enabling WHO prequalification, lenacapavir is poised to accelerate national regulatory processes and expand prevention choices for diverse populations worldwide.