June 18, 2025
This afternoon, the FDA approved Gilead’s drug, lenacapavir, a powerful HIV prevention drug that only requires two shots a year. The O’Neill Institute for National and Global Health Law issued the following statements from Jeffrey S. Crowley, director of the Center for HIV and Infectious Disease Policy; Matthew M. Kavanagh, director of the Center for Global Health Policy and Politics; and Dr. Charles B. Holmes, director of the Center for Innovation in Global Health.
Today’s FDA approval of lenacapavir (Yeztugo) for pre-exposure prophylaxis (PrEP) marks a significant milestone in the fight to end the HIV epidemic in the United States and around the world. While existing PrEP options are highly effective, access remains limited, and a range of barriers have impeded efforts to equitably scale up delivery to the people and places where PrEP is most needed. These include financing challenges, limited capacity and infrastructure to deliver PrEP at scale, stigma, and difficulties adhering to regimens that require daily pills or administrations several times per year. Globally, there are not yet affordable generic options to enable widespread access in Africa, Asia, and Latin America — how quickly that changes will dictate whether lenacapavir will have an impact on the pandemic worldwide.
“A safe and effective PrEP option that requires just two injections per year and does not need refrigeration deserves recognition. This is an exciting and important addition to our PrEP toolkit. Still, more work lies ahead, especially during this challenging moment. Preventing HIV in whole populations is hard and requires persistent, continuous effort. Now, we need to ensure that all people with a need for PrEP and who want this or other forms of PrEP have easy and reliable access to it,” said Jeffrey S. Crowley.
“Long-acting antiretrovirals could revolutionize the global response to AIDS. On average, research shows HIV innovations become widely available in the United States 10 years before they are in Africa,” said Matthew M. Kavanagh. “But this drug could be made affordably in factories in South Africa, Brazil, Thailand, and beyond. If that happens, and happens fast, it could be a major salve for the global crisis in HIV today.”
“Having worked extensively on the introduction of prior innovations within the global HIV response over the last two decades, lenacapavir is in a league of its own. Its development has been carefully tailored to the needs of people at risk of HIV, and it is highly effective,” said Dr. Charles Holmes. “If made widely accessible, lenacapavir can have a major impact on reducing the risk of HIV among the most vulnerable, and we’ve all got a responsibility to ensure that promise is met.”
“In the short term, Gilead committed to selling 2 million doses now to PEPFAR and the Global Fund, and it is essential that the irresponsible cuts to US aid programs do not derail this effort and that those 2 million doses reach people in need,” added Kavanagh. “Notwithstanding cutbacks at PEPFAR and the Global Fund, it is essential to ensure that Gilead’s interim commitment of 2 million doses gets administered to those who need them as we work to bring generic production online.”