FDA Approves Injectable LEN for PrEP

Dear Advocate,

AVAC welcomes the U.S. Food and Drug Administration (FDA) approval of injectable lenacapavir (LEN) as pre-exposure prophylaxis (PrEP). Developed by Gilead Sciences, LEN is a twice-yearly injectable PrEP option that showed nearly complete protection against HIV in the landmark PURPOSE 1 and 2 trials. Science Magazine named LEN the “Breakthrough of the Year” in 2024, a recognition that reflects its enormous potential. But that promise will only be realized if it is rolled out with speed, scale, and equity.

In our statement issued earlier today, we outline what’s needed from every stakeholder in the HIV response to meet this moment—and not squander yet another PrEP option.

As outlined in our Gears of Lenacapavir for PrEP Rollout, this moment demands unprecedented ambition, commitment, and leadership from governments, funders, implementers, policymakers, and civil society.

Please check out all of AVAC’s advocacy tools and resources to support our collective work in advancing equitable LEN rollout as part of comprehensive, integrated and sustained HIV programs.

This is the moment for all stakeholders to build on the momentum science. LEN has moved faster through regulatory review than any prevention product to date. Now it’s up to all of us to make sure that that progress translates into real, sustained impact on the epidemic, led by communities around the world.   

Let’s get to work. 

Best,

AVAC