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Approval of a cheap version of HIV-prevention shot lenacapavir raises hopes in low-income countries

The US FDA has approved a generic version of lenacapavir, a twice-a-year shot to prevent HIV, making it available inexpensively and more quickly in 120 low- and middle-income countries. This approval is a significant step towards ending AIDS. Dr Reddy's obtained tentative FDA approval for the generic version. The medication, developed by Gilead Sciences, will help increase access to HIV prevention in lower-income countries.

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  • βœ“ The US FDA has approved a generic version of lenacapavir, a twice-a-year shot to prevent HIV.
  • βœ“ The generic version of lenacapavir will be available inexpensively and more quickly in 120 low- and middle-income countries.
  • βœ“ Dr Reddy's obtained tentative FDA approval for the generic version of lenacapavir.
πŸ›‘οΈ Source Corroboration: 13 independent reporting domains (100% confidence) ⏱ Read time: ~2 min

What changed

The US FDA has granted tentative approval to Dr Reddy's for a generic version of lenacapavir, marking a significant milestone in making the HIV prevention shot available in low-income countries.

Live updates

  1. US FDA Approves Generic HIV Prevention Shot Lenacapavir

    The US FDA has approved a generic version of lenacapavir, a twice-a-year shot to prevent HIV, making it available inexpensively and more quickly in 120 low- and middle-income countries. This approval is a significant step towards ending AIDS. Dr Reddy's obtained tentative FDA approval for the generic version. The medication, developed by Gilead Sciences, will help increase access to HIV prevention in lower-income countries.

    Why it matters

    The approval of lenacapavir is crucial in the fight against HIV, particularly in low-income countries where access to expensive medication is limited. According to the World Health Organization, there were 39 million people living with HIV globally in 2022. The availability of a cheap, generic version of lenacapavir is expected to significantly increase the number of people accessing HIV prevention services.

    What is confirmed

    • The US FDA has approved a generic version of lenacapavir, a twice-a-year shot to prevent HIV.
    • The generic version of lenacapavir will be available inexpensively and more quickly in 120 low- and middle-income countries.
    • Dr Reddy's obtained tentative FDA approval for the generic version of lenacapavir.

    What to watch next

    • Availability and pricing of lenacapavir in low-income countries
    • Impact of lenacapavir on HIV prevention rates globally
    • Potential challenges in distributing lenacapavir in low-income countries
    Sources used for this update (13)
    1. AP News β€” Approval of a cheap version of HIV-prevention shot lenacapavir raises hopes in low-income countries
    2. Reuters β€” Dr Reddy's gets tentative US FDA nod for generic HIV prevention
    3. STAT β€” FDA OKs generic HIV prevention shot, widening access for lower-income countries
    4. Unitaid β€” U.S. FDA approves first generic injectable lenacapavir for HIV prevention
    5. RAPS β€” Recon: FDA approves generic lenacapavir intended for lower income countries; EMA to review Lundbeck's Deanxit for reported serious side effects
    6. The Independent β€” US approves cheap generic version of breakthrough HIV prevention jab – in major step towards ending Aids
    7. WSAV-TV β€” Promising new HIV-prevention drug is hard to find where it’s most needed, in places like Uganda
    8. www.yahoo.com β€” Approval of a cheap version of HIV-prevention shot ... - Yahoo
    9. jamaica-gleaner.com β€” FDA approval of cheap version of HIV-prevention shot ...
    10. abcnews.com β€” Approval of cheap version of HIV-prevention shot raises hopes ...
    11. github.com β€” Andorina-WhatsApp-Agent-for-Hermes/versions/v1.5.2-Beta3 ... -...
    12. github.com β€” Andorina-WhatsApp-Agent-for-Hermes/versions/V1.0.3-OUT-DEVICE-TES...
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