A twice-yearly jab that almost wiped out new HIV infections in trials is set to reach Africa and other low-income regions for just $40 a year, after US regulators cleared the first generic version.
Main image: DGBN graphic. Photo: Gkamadi / Wikimedia Commons, CC BY-SA 4.0
What has been approved
The US Food and Drug Administration on Monday approved a generic form of lenacapavir made by India’s Dr Reddy’s Laboratories, the company and the global health agency Unitaid announced. The approval is classed as “tentative”, the FDA’s standard label for generics while the original brand remains under patent in the United States.
It was granted under the FDA process linked to PEPFAR, the US President’s Emergency Plan for AIDS Relief, which checks the quality of HIV medicines supplied to other countries. An FDA nod can speed up approvals in many national regulators.
From $28,000 to $40
Lenacapavir was developed by Gilead Sciences and approved in the US in 2025, where its brand-name version, Yeztugo, carries a list price of about $28,000 a year before insurance. In large clinical trials it proved more than 99.9 per cent effective at preventing infection.
The generic will cost $40 per person per year in 120 low- and middle-income countries, under a pricing deal struck in September 2025 between Dr Reddy’s, Unitaid, the Clinton Health Access Initiative (CHAI) and Wits RHI, the Johannesburg-based health research institute. That is the same price as the daily preventive pills already in use.
Gilead granted royalty-free licences to six generic manufacturers in late 2024, covering countries in sub-Saharan Africa, Asia and Latin America. Until now, it has been the sole supplier, and demand in poorer countries has outstripped supply. A Gilead spokesperson said the company shared “the sense of urgency” around expanding access, according to the Associated Press.
Why a jab changes the game
Daily PrEP pills only work if taken consistently, and many people struggle to do so. Two injections a year remove that burden. Unitaid says more than 125,000 people in 10 early-adopter African countries had already started Gilead’s lenacapavir before any generic was available.
CHAI’s HIV lead Carolyn Amole told the AP that an affordable generic could help scale prevention to the 20 million people worldwide who need PrEP, and “actually begin to bring an end to the HIV epidemic”. The first supplies could arrive in some countries within weeks, though states that require their own regulatory sign-off may take longer.
Why it matters to Black communities
Sub-Saharan Africa carries the heaviest HIV burden on earth, and young women in eastern and southern Africa remain among the most exposed. In the United States and the UK, Black communities also account for a disproportionate share of new diagnoses. According to the WHO, 41 million people were living with HIV worldwide last year and 570,000 died from HIV-related causes.
The science is now affordable. The test ahead is money and delivery. As Amole put it, the next step is finding “the funding to actually buy it for everyone who needs it” and getting it into the arms of the millions who want it.