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USFDA okays Lenacapavir: Affordable, generic India-made drug key to boost global HIV prevention

June 21, 2025

New Delhi, June 20

While Gilead Sciences’ HIV prevention drug lenacapavir got approved by the US Food and Drug Administration (FDA), its made-in-India generic versions may be a more affordable alternative that can boost the prevention of the deadly condition globally.

In a major breakthrough, the US FDA this week approved lenacapavir -- a long-acting injectable drug that offers near-complete protection against HIV with just two doses a year.

Marketed under the brand name Yeztugo, the world’s first twice-yearly HIV prevention shot can potentially, transform pre-exposure prophylaxis (PrEP) options. The drug may be particularly crucial for those who struggle with daily medication adherence due to stigma, access issues, or lifestyle factors.

However, the high cost -- at $28,218 per person per year -- is likely to act as a deterrent to global HIV prevention goals.

Although USFDA approval is a big thing, the “real breakthrough would be when lenacapavir becomes accessible, affordable and available to all those in need," said Dr Ishwar Gilada, Secretary General of People’s Health Organisation (PHO).

Earlier the UNAIDS also urged Gilead to drop the price of lenacapavir HIV prevention shot.

 

 

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