Unitaid welcomes U.S. FDA approval of lenacapavir and calls for urgent action on affordability and access

Unitaid welcomes the U.S. Food and Drug Administration’s approval of lenacapavir for HIV prevention – a promising tool that could reshape how those most at risk of infection can protect themselves. A twice-yearly injectable, lenacapavir has the potential to close major gaps in access, particularly for people underserved by existing tools.

This approval is another key milestone in the pathway for lenapacavir to reach impact. But as of today, no clear price for lenacapavir has been announced by Gilead for low- and middle-income countries. Early indications suggest that it could be priced higher than other prevention options such as oral PrEP, potentially putting this innovation out of reach for the communities who need it most, despite estimations that it can be produced at a much lower cost.  Unitaid, together with partners, is working to ensure that quality-assured, lowest-cost generics become available as soon as possible. In the meantime, access to Gilead’s product will be critical.

Lenacapavir can play a critical role in ending the HIV epidemic, a crisis that has devastated millions of lives and continues to burden communities worldwide. Unitaid urges Gilead to build on the leadership it has shown with its geographically diverse and inclusive clinical trials, by committing to a transparent and equitable pricing approach that reflects the realities faced by health systems in low- and middle-income countries. An affordable price will be essential to translating the potential of this innovation into impact, and Unitaid remains committed to supporting efforts that make broad, affordable access a reality.

Unitaid, working with communities and countries, has a long track record of expanding access to the full suite of HIV prevention tools, from oral PrEP to our pioneering investments in long-acting injectable cabotegravir and the dapivirine vaginal ring. Building on this foundation, we moved early to support access to lenacapavir. In 2024, Unitaid launched a US$22 million investment to support countries’ needs for sustainable introduction and adoption of lenacapavir. This work includes working with partners to quickly bring affordable, quality-assured generics to market, supporting country-led rollout of lenacapavir, and ensuring communities most affected by HIV are involved at every step. In addition, Unitaid is supporting rapid development of WHO guidelines, expected to be released at the 13th IAS Conference on HIV Science in July 2025, as well as WHO prequalification.

Now that lenacapavir has received its first approval for use in prevention, we need to continue working quickly and strategically to unlock all barriers to ensure this innovation doesn’t sit on the shelf. Significant efforts are underway but more is needed. To turn lenacapavir’s promise into public health impact, we must pair a low-cost, quality-assured product with efficient, integrated delivery models that reach all people most at risk – especially in a constrained funding environment where many vulnerable populations may face new barriers to accessing services.

Unitaid remains committed to supporting cost-efficient, sustainable, locally driven systems that enable broad uptake and scale, and to continue working with partners and communities across the HIV response to ensure lenacapavir delivers on its life-saving potential. Unitaid calls on industry and all stakeholders to deliver, in partnership, on the promise of lenacapavir. History has shown what’s possible when the global health community comes together with urgency and purpose. This is one of those moments, and it must not be missed.