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The US Food and Drug Administration (FDA) has approved the first generic version of Lenacapavir, the biannual HIV prevention vaccine described as the world’s closest thing to a vaccine, paving the way for this breakthrough drug to reach millions of people in the hardest-hit countries.
The United Nations says lenacapavir, made by US pharmaceutical giant Gilead Sciences, could be key to achieving the goal of ending the AIDS epidemic by 2030.
Lenacapavir is currently available in the United States, but at a high price of more than $28,000 per year. The generic, developed by Dr. Reddy’s Indian Laboratories, will cost just $40 per person per year and will be available in 120 low- and middle-income countries under an existing partnership agreement negotiated by global health initiative Unitaid, the Clinton Health Access Initiative and Wits RHI, an African health research institute.
Zambia is expected to be the first country to receive these supplies.
Carmen Pérez Casas, HIV manager at Unitaid, said The Independent that the more people who contract HIV, the more difficult the epidemic is to control, “so we absolutely must reduce the number of infections. This tool is really promising.” She added that with no vaccine yet, this is “the closest time to having an opportunity.”
But the generic required FDA approval for distribution, which was obtained in record time. Today’s announcement comes approximately 16 months after the FDA approved the original version. For example, life-saving antiretroviral therapy was available in the West for a full decade before reaching sub-Saharan Africa, a delay that cost countless lives.
“It has never been faster for the generic product to arrive so quickly after the approval of the originator,” continued Ms. Pérez Casas.
“Less than 16 months after Gilead, the original product, was approved by the US FDA, today we have a generic-made injectable lenacapavir priced at $40 that has also received FDA approval,” she said. “Normally it takes about a decade.”
The approval comes at a critical time. Around 1.2 million people become infected with HIV each year, most in low-income countries.
At the start of 2025, the world was on track to end the AIDS pandemic by 2030, but unprecedented cuts in aid from the United States, the United Kingdom and other European countries have caused the greatest disruption ever seen in the HIV response, from testing to treatment and prevention. The Independent’s own modeling found that if cuts continue, there could be millions more deaths and infections.
Until now, Gilead was the sole supplier of lenacapavir, selling only small quantities at lower prices to poorer countries, with demand far outstripping supply. Gilead granted voluntary licenses to six generic manufacturers and Unitaid selected Dr Reddy’s from among them to market an affordable version as quickly as possible.
“With Gilead alone, we cannot meet this demand because they are not producing enough,” Ms. Pérez Casas said.
The U.S. government and the Global Fund have committed to reaching three million people by 2028. Experts estimate that about 20 million people need to be on PrEP to bring the epidemic under control, ideally half of them on injections.
So far, according to Unitaid, 175,000 people have received a dose of lenacapavir. The Independent visited Eswatini where vaccines were being rolled out – there, clinicians said they were already sold out and demand was high.
FDA approval is crucial because, under rules dating back to the early 2000s, antiretroviral drugs purchased with U.S. funding must be approved by the U.S. regulator, even if they are never sold in the United States. It also allows other countries, as well as the World Health Organization, to expedite their own approvals.
Zambia is expected to be among the first countries to receive the generic before the end of 2026, with Unitaid hoping supplies will arrive by World AIDS Day on December 1.
But the agreement still leaves gaps. The 120 countries covered by Gilead’s licenses exclude countries accounting for at least 10 percent of global infections, some with growing outbreaks, including Brazil, where some of the clinical trials took place.
“We hope that in the near future these countries will indeed have the possibility to also access low-cost generics,” said Ms. Pérez Casas.
This article was produced as part of The Independent’s research. Rethinking global aid project
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