US approves cheap generic version of breakthrough HIV prevention jab – in major step towards ending Aids

The US Food and Drug Administration (FDA) has approved the first generic version of Lenacapavir, the twice-yearly HIV prevention jab described as the closest thing the world has to a vaccine, paving the way for the breakthrough drug to reach millions of people in the hardest-hit countries.The United Nations believes Lenacapavir, which is made by US pharmaceutical giant Gilead Sciences, could be key to reaching the goal of ending the Aids epidemic by 2030.Lenacapavir is currently available in the US, but with a hefty price tag of more than $28,000 a year. The generic, developed by India’s Dr Reddy’s Laboratories, will cost just $40 per person per year and be made available in 120 low- and middle-income countries under an existing partnership agreement brokered by global health initative Unitaid, the Clinton Health Access Initiative and Wits RHI, a health research institute in Africa.Zambia is expected to be the first country to get the supplies. Carmen Pérez Casas, HIV lead at Unitaid, told The Independent that the more people who acquire HIV, the harder the epidemic is to control, “so we absolutely need to cut the number of infections. This tool really holds a promise.” She added that with no vaccine yet, this is “the closest we are to having an opportunity”.But the generic required FDA approval to be distributed, which was achieved in record time. Today’s announcement comes around 16 months after the FDA approved the original version. Life-saving antiretroviral therapy, for example, was available in the West for a full decade before it reached sub-Saharan Africa, a delay that cost countless lives.“It has never been so fast that the generic product comes so soon after the originator is approved,” Ms Pérez Casas continued.Lianne, a sex worker, gets Lenacapavir the 'miracle' HIV prevention drug for the first time (Bel Trew/The Independent)“In less than 16 months since Gilead, the originator product, was approved by the US FDA, we have today a lenacapavir injectable manufactured by the generics at a $40 price that has received FDA approval as well,” she said. “Normally, you require around a decade.”The approval comes at a critical moment. Around 1.2 million people are infected with HIV every year, many in low-income countries.At the start of 2025 the world was on track to end the Aids pandemic by 2030, but unprecedented aid cuts from the US, the UK and other European countries have caused the biggest ever disruption to the HIV response, from testing to treatment and prevention. The Independent’s own modelling found that if the cuts continue, there could be millions more deaths and infections.Until now Gilead has been the sole supplier of lenacapavir, selling only small quantities at cheaper prices to poorer nations, with demand far outstripping supply. Gilead granted voluntary licences to six generic manufacturers, and Unitaid selected Dr Reddy’s from among them to bring an affordable version to market as quickly as possible.“With Gilead alone, there is no way we can meet that demand because they are not producing enough,” Ms Pérez Casas said.The US government and the Global Fund have committed to reaching three million by 2028. Experts estimate around 20 million people need to be on PrEP to bring the epidemic under control, ideally half of them on the injection.Lenacapavir is so popular they have already run out in Eswatini (Bel Trew/The Independent)So far, according to Unitaid, 175,000 people have received one dose of lenacapavir. The Independent travelled to Eswatini where the jabs were being rolled out - there clinicians said they had already run out and demand was high. FDA approval is crucial because, under rules dating back to the early 2000s, antiretrovirals bought with US funding must be approved by the US regulator, even if they are never sold in America. It also allows other countries, and the World Health Organization, to fast-track 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 arrive by World Aids Day on 1 December.But the deal still leaves gaps. The 120 countries covered by Gilead’s licences exclude nations accounting for at least 10 per cent of global infections, some with rising epidemics, including Brazil, where part of the clinical trials took place.“We hope that in near future, yes, there could be a possibility for those countries to also access the low-cost generics,” Ms Pérez Casas said.This article has been produced as part of The Independent’s Rethinking Global Aid project