On Wednesday, June 18, 2025, the U.S. Food and Drug Administration (FDA) gave the green light to lenacapavir, also known as Yeztugo, a groundbreaking HIV prevention manufactured by Gilead Sciences.
After nearly twenty years of hard work and research, this exciting twice-a-year injectable offers a major leap forward in the fight against HIV, particularly for adults and adolescents weighing at least 35 kg.
The FDA’s approval was backed by impressive findings from the Phase 3 PURPOSE 1 and PURPOSE 2 clinical trials, which revealed that over 99.9% of participants stayed HIV-negative over two years a result highlighted in the New England Journal of Medicine in 2024. Conducted in South Africa and Uganda with more than 5,300 sexually active young women and adolescent girls, these trials showcased the drug’s remarkable effectiveness compared to traditional daily oral PrEP (pre-exposure prophylaxis) methods.
However, there’s a cloud hanging over this promising development due to its hefty price tag.
Gilead has priced the annual cost at $28,218 per person, which sharply contrasts with research from the University of Liverpool published in The Lancet HIV. This research estimates that generics could be produced for only $25 to $46 per person per year while still providing a profit margin.
This eye-watering markup raises important questions about accessibility, especially in low- and middle-income countries where 95% of the world’s new HIV infections occur, according to the World Health Organization (WHO).
For people in developing nations like Uganda, the annual price of around 101 million Ugandan Shillings can mean decades of income, making it out of reach for many.
Winnie Byanyima, the Executive Director of UNAIDS, has been vocal about her concerns regarding Gilead’s pricing, stating, “Millions of poor girls and young women in Africa, who are most at risk of HIV infection, will not get this 100% protection because Gilead wants to maximize profits. This is not acceptable. Gilead, you can be part of ending new infections and ending AIDS.”
She’s calling for price reductions, especially given Gilead’s existing agreements with six generic manufacturers, which allow for royalty-free production in 120 high-incidence, low-income countries.
As of 2023 UNAIDS report, approximately 1.4 millions Ugandans are living with HIV.
Gilead has also pledged to provide up to 2 million doses at cost until generics become available, a step aimed at helping those in need. But some experts worry that this supply may fall short, as it typically takes treating 40–50 individuals to prevent just one infection so those 2 million doses might cover only a small portion of the global demand.
The approval of Yeztugo has sparked discussion around the world, with many celebrating it as a great scientific milestone that offers a discreet, long-acting alternative to daily pills. Others are expressing concerns about the barriers its high cost presents.
The CEO Daniel O’Day highlighted the significance of the drug’s approval but recognized the need for wider access strategies. With European Union approval expected later in 2025, there’s hope for improved distribution in low-resource areas.
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