FDA Approval: Cheap HIV Shot Set for Global Rollout

The U.S. Food and Drug Administration granted approval on Monday to a generic version of lenacapavir, the only available twice-yearly injection for HIV prevention. This regulatory move clears the path for the drug to be distributed at a lower cost across 120 low- and middle-income countries.

The primary benefit of this approval is the projected reduction in price for patients in developing regions. Manufacturers estimate the generic medication will cost $40 U.S. per person annually. This price point matches the current cost of daily preventive pills, but the injection offers a distinct advantage in convenience. Clinical trials indicated that the biannual shot nearly eliminated new infections among high-risk participants, removing the burden of daily adherence.

Carmen Pérez Casas, the HIV lead for Unitaid, noted that previous daily regimens lost protection if doses were missed. "With lenacapavir, we are much more hopeful," she said. Carolyn Amole, who directs the HIV program at the Clinton Health Access Initiative, stated that an affordable generic option could allow health systems to scale treatment to the 20 million people worldwide who need pre-exposure prophylaxis. She added that reaching that population size could begin to end the HIV epidemic.

The approval comes as global demand for the medication outpaces current supply. Gilead Sciences, the maker of the brand-name drug Yeztugo, has been the sole supplier until now. The brand-name version retails for $28,218 U.S. annually in the United States before insurance. Gilead established royalty-free licensing agreements with six generic manufacturers last year to increase production. The licenses cover specific areas in sub-Saharan Africa, Asia, and Latin America. A Gilead spokesperson said the company believes it has enabled the fastest path to expanding access for communities most affected by HIV.

South Africa began rolling out the brand-name drug earlier this year, serving a population of approximately eight million people living with HIV. The Global Fund to Fight AIDS, Tuberculosis and Malaria signed an agreement with Gilead in 2025 to provide the medication to low- and middle-income countries. Officials in South Africa noted in August that only a generic version would allow the rollout to happen at scale. The World Health Organization reported that 41 million people were living with HIV and 570,000 died from HIV-related causes last year.

Dr. Reddy’s Laboratories, based in India, developed the generic version under an agreement brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI. The FDA designated the approval as tentative, a standard designation for generics while the original patent remains active. Generic lenacapavir cannot be sold in the U.S. or Canada yet because the brand-name patent is still protected. Health Canada approved the brand-name drug earlier this year, but Gilead is still negotiating its addition to the public system.

The generic medication is expected to become available in some locations within weeks. Other countries may take longer if they require their own regulatory approval processes. Side effects include injection site reactions, headache, and nausea. Patients must undergo HIV testing before starting the drug and with each injection to prevent drug-resistant strains in those with undiagnosed infections.