Low-cost generic of twice-yearly HIV prevention shot wins FDA approval, raising hopes in poorer nations

A generic form of the world's only twice-a-year injection that prevents HIV has been approved by the U.S. Food and Drug Administration, a move that health organizations say could make the life-saving medication affordable and widely available across 120 low- and middle-income countries.

The approval of the drug, known as lenacapavir, was announced on Monday by its manufacturer together with the organizations that helped accelerate its development. In the countries where it will be distributed, the medication is expected to cost $40 US per person each year.

That price matches the cost of the daily preventive pills already on the market. But the injectable version is far more convenient because it is administered only twice a year, and it nearly eliminated new infections in two groundbreaking studies involving people at high risk. Carmen Pérez Casas, HIV lead for the grant-making organization Unitaid, said that until now people who forgot or were unable to take a daily dose lost their protection against the virus. "With lenacapavir, we are much more hopeful," she said.

Advocates believe the medication could ultimately help reduce HIV and AIDS cases as well as deaths. The World Health Organization says 41 million people worldwide were living with HIV last year, and 570,000 died from HIV-related causes. Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, said an affordable, high-quality generic could help reach "the 20 million people around the world who need PrEP," the prescription medicine taken by at-risk people before exposure to the virus. "And if we scale to those levels," she said, "we can actually begin to bring an end to the HIV epidemic."

The generic cannot be sold in the United States, where Gilead Sciences' brand-name version, Yeztugo, was approved last year and remains under patent protection. Yeztugo costs $28,218 US annually before insurance, a price Gilead officials say is comparable to other forms of pre-exposure prophylaxis. The drug is marketed as Yeytuo in Canada and the European Union; Health Canada approved it earlier this year, but Gilead is still negotiating its inclusion in the public system.

The FDA cleared the new generic under a long-standing practice meant to ensure the quality of HIV drugs supplied to other countries by the U.S. government, and such approval can speed up regulatory decisions elsewhere. The clearance is considered "tentative," the agency's standard label for generics while the original product remains patented. Until now Gilead has been the sole supplier of lenacapavir, and demand in low- and middle-income countries has outpaced supply. Last year Gilead signed royalty-free licensing agreements with six generic manufacturers covering specific countries in sub-Saharan Africa, Asia and Latin America. "We share the sense of urgency around expanding access to lenacapavir for HIV prevention," a Gilead spokesperson said.

Roll-out of lenacapavir began earlier this year in South Africa, home to the world's largest population of people living with HIV at around eight million. Access was arranged through The Global Fund to Fight AIDS, Tuberculosis and Malaria, which signed an agreement with Gilead in 2025. Officials said in August that only a generic version would allow distribution at scale.

The approved generic was developed by India-based Dr. Reddy's Laboratories under an agreement brokered by Unitaid, the Clinton Health Access Initiative and Wits RHI, an African health research institute. Common side effects of lenacapavir include injection site reactions, headache and nausea. Patients must be tested for HIV before starting the drug and with each injection, because drug-resistant HIV has been identified in cases where people with undiagnosed infections used it.

Those involved in the effort say the generic should begin reaching some places within weeks, though it may take longer in countries that require their own approval processes. Versions from the other licensed manufacturers have yet to receive FDA approval. "The work is not done," Amole said, noting that funding and distribution remain challenges. "But this is a great milestone." Casas said she is optimistic that scientific progress, political will and funding can help curb the epidemic. "Now," she said, "we have the tools."