The Food and Drug Administration on Wednesday granted approval for Gilead Sciences’ twice-yearly injectable HIV prevention medication, a milestone that the company and some epidemiologists have said could be a monumental step toward ending the decadeslong HIV/AIDS epidemic. 

The new medication, which will be marketed as Yeztugo, is an injectable HIV pre-exposure prophylaxis, or PrEP, making it a much more convenient and accessible tool for HIV prevention than existing oral medications. 

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The approval comes after two successful large clinical trials with nearly perfect results. 

The first trial, conducted in women across South Africa and Uganda in 2024, found that Yeztugo had an unprecedented 100% efficacy rate, with no HIV infections observed in the treatment group and better results compared to the once-daily PrEP pill Truvada, also made by Gilead.

The second trial focused on a broader population that included gay and bisexual men across the world. Only two HIV infections were reported among the more than 2,000 participants who took Yeztugo.

The generic version of Yeztugo, Lenacapavir, boasts an annual list price of more than $28,000 in the United States before insurance, a Gilead spokesperson told CNBC. That’s about equivalent to Gilead’s $2,000 per month price tag for Truvada before insurance. 

The Supreme Court is currently weighing a lawsuit involving an Obamacare preventive coverage mandate for PrEP oral medication.

Although the initial challenge was specifically regarding PrEP, the case calls into question the validity of all decisions made by the U.S. Preventive Services Task Force, which sets preventive coverage recommendations. Oral arguments in the case are expected by the end of June.

Some experts have also said that the spending reductions for Medicaid in the GOP’s 2026 reconciliation bill, the One Big Beautiful Bill Act, would have devastating consequences for HIV-positive patients. Medicaid covers 40% of non-elderly adults with HIV, according to the health policy think tank KFF. 

In 2022, an estimated 31,800 people aged 13 and older acquired HIV in the U.S. About 1.2 million people in the U.S. have HIV, and about 13% of them don’t know that they have it.

Regarding global access to the promising drug, Gilead has already established agreements with six drugmakers giving them a royalty-free license to make low-cost versions of the injectable PrEP.

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According to the United Nations, there were roughly 1.3 million new HIV infections in 2023. Nearly 40 million people worldwide were living with HIV in 2023, and about 630,000 died from an AIDS-related illness in 2023. 

Women and girls accounted for 44% of all new HIV infections last year and make up more than half, 53%, of the people worldwide living with the condition. Roughly 1.4 million children under age 14 are living with HIV.