The U.S. Food and Drug Administration has approved a generic version of the world’s only twice-a-year shot to prevent HIV — a big step toward making the drug available inexpensively and more quickly in 120 low- and middle-income countries.
The announcement was made on Monday morning by the manufacturer and organizations that helped to speed up development of the medication, called lenacapavir.
The drug is expected to cost $40 US a year per person in the countries where it will be available.
It’s the same price as the daily preventive pills that are available now. But the shots are much more convenient than the pills because they’re needed much less frequently and they nearly eliminated new infections in two groundbreaking studies of people at high risk.
Up until now, if people forgot or were unable to take the daily dose of medication, they would lose that protection against HIV, said Carmen Pérez Casas, HIV lead for the grant-making organization Unitaid, a global health agency. “With lenacapavir, we are much more hopeful.”
Ultimately, advocates said, the medication should help drive down cases of HIV and AIDS, as well as deaths. According to the World Health Organization, 41 million people worldwide were living with HIV and 570,000 died from HIV-related causes last year.
A medical clinician prepares to administer a dose of lenacapavir to a client during the launch of the HIV prevention drug in Kisumu, Kenya, on March 7. (James Keyi/Reuters)
With an affordable, high-quality generic medication now available, “we could help to scale this to the 20 million people around the world who need PrEP,” prescription medicine taken by people at risk of HIV before being exposed to the virus, said Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, a global health organization.
“And if we scale to those levels,” she said, “we can actually begin to bring an end to the HIV epidemic.”
Brand-name version retails in U.S. for $28K US
Generic lenacapavir can’t be sold in the U.S. because a brand-name version, Yeztugo, made by Gilead Sciences and approved last year, is still protected by a patent.
The U.S. price for Yeztugo, which is delivered as twice-yearly injections, is $28,218 US a year before insurance. Gilead officials say that’s similar to some other types of PrEP, which stands for pre-exposure prophylaxis.
Yeztugo is known as Yeytuo in Canada and the European Union. It was approved by Health Canada earlier this year, but Gilead is still negotiating its addition to the public system.
The new generic was approved by the FDA under a long-standing practice designed to ensure the quality of HIV-related drugs provided to other countries by the U.S. government. Approval of a drug by the U.S. FDA can speed regulatory approval in many other countries. The approval is considered “tentative,” the FDA’s standard designation for generics while the originator remains under patent.
The U.S. Food and Drug Administration has approved a drug called lenacapavir — a twice-a-year shot to protect against HIV infection. Experts say the preventative medication brings the possibility of ending HIV transmission.
Until now, Gilead has been the sole supplier of lenacapavir, and demand has outstripped supply in low- and middle-income countries.
Last year, Gilead established royalty-free licensing agreements with six generic manufacturers to enable production. Those voluntary licences cover a specific set of 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 in a statement. “We believe we have enabled the fastest and most sustainable path to expanding access for communities most affected by HIV.”
Earlier this year, roll-out of lenacapavir started in South Africa, which has the biggest population of people living with HIV in the world at around eight million. Access was provided by The Global Fund to Fight AIDS, Tuberculosis and Malarai, who signed an agreement with Gilead in 2025 for lenacapavir for low- to middle-income countries. But officials noted in August that only a generic version would allow them to do the roll-out at scale.
Thandeka Shabangu, a nurse, holds lenacapavir before administering it to a patient at a mobile clinic in Secunda, South Africa, on June 5. (Kayleen Morgan/The Associated Press)
Generic should be available soon
The generic was developed by India-based Dr. Reddy’s Laboratories under an agreement brokered by Unitaid, the Clinton Health Access Initiative and Wits RHI, a health research institute in Africa. The partners sought to accelerate development and make the drug available at an affordable price.
Common side effects with lenacapavir include injection site reactions, headache and nausea. People also must be tested for HIV prior to starting the drug and with each injection; drug-resistant HIV has been identified when used by people with an undiagnosed HIV infection.
New federal data shows HIV cases in Canada rose 23 per cent in 2024 compared with 2022, with more cases appearing in small communities that lack adequate healthcare. Experts worry U.S. cuts to international AIDS funding could trigger more resurgence of HIV/AIDS around the world.
Generic lenacapavir should start to become available in some places within weeks, those helping with the effort said, although it could take a bit longer in countries that require the drug to go through their own approval processes before people can start taking it. Generic versions made by the other manufacturers have yet to be approved by FDA.
“The work is not done. Now, we need the funding to actually buy it for everyone who needs it and then we need to do the hard work of getting it to the millions of people who need it and want it,” Amole said. “But this is a great milestone.”
Casas said she’s optimistic that scientific advances, along with political will and funding, can help the world curb HIV.
“Now,” she said, “we have the tools.”
About the Author
