US approves first generic lenacapavir HIV prevention jab at $40 a year
The US FDA has approved the first generic version of lenacapavir, a twice-yearly HIV prevention injection made by India's Dr Reddy's Laboratories. It will cost $40 per person per year in 120 low- and middle-income countries.
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- FDA approves first generic lenacapavir, a twice-yearly HIV prevention jab
- Generic costs $40 per person a year, against more than $28,000 for the Gilead brand in the US
- Available in 120 low- and middle-income countries; Zambia expected to receive it first
The US Food and Drug Administration has approved the first generic version of lenacapavir, a twice-yearly injection that prevents HIV infection. The generic was developed by India's Dr Reddy's Laboratories, according to The Independent.
The generic will cost $40 per person per year. The brand-name product made by Gilead Sciences costs more than $28,000 a year in the US. It will be made available in 120 low- and middle-income countries under an existing partnership agreement brokered by Unitaid, the Clinton Health Access Initiative and Wits RHI.
Zambia is expected to be the first country to receive supplies, before the end of 2026. Unitaid hopes they will arrive by World Aids Day on 1 December.
The approval came around 16 months after the FDA cleared the original Gilead version. It was required because antiretroviral drugs bought with US funding must be approved by the US regulator. It also allows other countries and the World Health Organization to fast-track their own approvals.
Gilead had been the sole supplier of lenacapavir, selling only small quantities at cheaper prices to poorer nations. It granted voluntary licences to six generic manufacturers, and Unitaid selected Dr Reddy's. The licences exclude nations accounting for at least 10 per cent of global infections, including Brazil.
According to Unitaid, 175,000 people have received one dose so far. Clinicians in Eswatini said the jabs had already run out and demand was high. Carmen Pérez Casas, HIV lead at Unitaid, said: "With Gilead alone, there is no way we can meet that demand because they are not producing enough". She also said: "This tool really holds a promise."
Around 1.2 million people are infected with HIV every year. Aid cuts from the US, the UK and other European countries have caused the biggest ever disruption to the HIV response, and The Independent's own modelling found continued cuts could mean millions more deaths and infections. The US government and the Global Fund have committed to reaching three million people by 2028, while experts estimate around 20 million need to be on PrEP to bring the epidemic under control. The UN believes lenacapavir could be key to ending the Aids epidemic by 2030.
Why it matters
A cheaper approved HIV prevention option matters to Pakistan's health services and the people they serve. The FDA approval also lets other countries and the World Health Organization fast-track their own approvals.
