India's Dr Reddy's wins first US FDA nod for a $40-a-year generic HIV-prevention shot
The Hyderabad drugmaker's version of lenacapavir, an injection given just twice a year, is meant for 120 low- and middle-income countries.
- Dr Reddy's is one of six licensed generic makers
- Aimed at 120 low- and middle-income countries
- About 41 million people live with HIV worldwide (WHO)
What happened
The US Food and Drug Administration has given tentative approval to the first generic version of lenacapavir, a twice-yearly injection that protects people from HIV. It was made by India's Dr Reddy's Laboratories. 'Tentative' is the FDA's usual label for a generic while the original drug is still under patent, so it cannot be sold in the US. Gilead's brand-name version lists at about $28,218 a year there.
Why it matters
The generic is expected to cost around $40 per person a year in the 120 countries covered by Gilead's royalty-free licences, roughly what daily PrEP pills cost now. In trials, the shots nearly stopped new infections among high-risk people. Unitaid, the Clinton Health Access Initiative and Wits RHI backed the work, and the first supplies could arrive within weeks. Health groups say money is still needed to buy enough doses.
