Uganda’s National Drug Authority (NDA) has approved the use of lenacapavir, a twice-yearly HIV prevention (PrEP) injection manufactured by Gilead Sciences, a U.S.-based company.
The approval is a game-changer for HIV prevention, especially for people at high risk of infection. It marks a significant step toward ending AIDS by 2030.
This development comes barely six months after the United States Food and Drug Administration (FDA) approved long-acting injectable lenacapavir for HIV prevention.
The new medicine is administered by injection once every six months and represents a major improvement in prevention options for people at risk of HIV infection worldwide.
In an interview, Gilead Sciences announced a U.S. list price of $28,218 (about Shs 101,574,641) per person per year.
However, a research paper published this week in The Lancet HIV found that generic lenacapavir could cost between $35 (Shs 12,598) and $46 (Shs 165,583) per person per year. The cost could fall further to $25 (Shs 89,991) per person per year if there is committed demand of five to ten million people within the first year, bringing the price in line with—or even lower than—current oral PrEP.
Responding to news of lenacapavir’s FDA approval, Winnie Byanyima, Executive Director of UNAIDS and United Nations Under-Secretary-General, said:
“This is a breakthrough moment. The approval of lenacapavir is a testament to decades of public investment, scientific excellence, and the contributions of trial participants and communities.”
“I congratulate Gilead and U.S. partners for advancing this important innovation. Lenacapavir could be the tool we need to bring new infections under control—but only if it is priced affordably and made available to everyone who could benefit,” she added.
“UNAIDS has seen research showing that lenacapavir can be produced for just $40 per person per year, falling to $25 within a year of rollout. It is beyond comprehension how Gilead can justify a price of $28,218. If this game-changing medicine remains unaffordable, it will change nothing. I urge Gilead to do the right thing: drop the price, expand production, and ensure the world has a real chance at ending AIDS.”
