US approves cheap generic version of breakthrough HIV prevention jab
The U.S. Food and Drug Administration approved a low-cost generic version of lenacapavir, a twice-yearly injectable for HIV prevention. Produced by Indian manufacturer Dr Reddy's Laboratories, the generic drug will be available for $40 per person per year in 120 countries. This approval comes 16 months after the original drug was authorized. The move aims to increase access to the breakthrough prevention method in low-income regions where the original medication remains difficult to obtain.
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- ✓ The FDA approved the first generic version of the twice-yearly HIV prevention injection lenacapavir.
- ✓ Dr Reddy's Laboratories is the Indian manufacturer of the generic lenacapavir.
- ✓ The generic version will cost $40 per person per year in 120 countries.
- ✓ The generic approval occurred 16 months after the approval of the originator drug.
What changed
The FDA granted approval for Dr Reddy's Laboratories to produce a generic version of the lenacapavir injection.
Live updates
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FDA approves first generic version of lenacapavir HIV prevention injection
The U.S. Food and Drug Administration approved a low-cost generic version of lenacapavir, a twice-yearly injectable for HIV prevention. Produced by Indian manufacturer Dr Reddy's Laboratories, the generic drug will be available for $40 per person per year in 120 countries. This approval comes 16 months after the original drug was authorized. The move aims to increase access to the breakthrough prevention method in low-income regions where the original medication remains difficult to obtain.
Why it matters
Lenacapavir is the only available HIV prevention shot administered just twice a year. Increasing its availability is viewed as a significant step toward ending the Aids epidemic. This generic version specifically targets accessibility in low-income countries.
What is confirmed
- The FDA approved the first generic version of the twice-yearly HIV prevention injection lenacapavir.
- Dr Reddy's Laboratories is the Indian manufacturer of the generic lenacapavir.
- The generic version will cost $40 per person per year in 120 countries.
- The generic approval occurred 16 months after the approval of the originator drug.
What to watch next
- Distribution timelines for the generic shot in low-income countries
- Implementation of the $40 pricing model across the 120 targeted nations
confidence 100%Sources used for this update (11)
- Reuters — Dr Reddy's gets tentative US FDA nod for generic HIV prevention
- Unitaid — U.S. FDA approves first generic injectable lenacapavir for HIV prevention
- The Independent — US approves cheap generic version of breakthrough HIV prevention jab – in major step towards ending Aids
- ABC News - Breaking News, Latest News and Videos — Approval of a cheap version of HIV-prevention shot lenacapavir raises hopes in low-income countries
- AP News — Promising new HIV-prevention drug is hard to find where it's most needed, in places like Uganda
- nz.news.yahoo.com — US approves cheap generic version of breakthrough HIV prevention jab – in major step towards ending Aids - Yahoo
- westernmorning.news — US approves cheap generic version of breakthrough HIV prevention jab – in major step towards ending Aids | Western Morning News
- www.yahoo.com — US approves cheap version of breakthrough HIV prevention shot ...
- www.jamaicaobserver.com — US approves cheap version of breakthrough HIV prevention shot ...
- www.independent.co.uk — Approval of a cheap version of HIV-prevention shot ...
- www.clintonhealthaccess.org — U.S. FDA approves first generic injectable lenacapavir for ...
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