The FDA approved a cheaper generic HIV-prevention shot
The US Food and Drug Administration on Monday approved a low-cost generic version of lenacapavir, a twice-yearly HIV-prevention shot, bringing it closer to availability in low-income countries. Unitaid senior strategy lead for HIV and pandemic preparedness Carmen Perez-Casas said an FDA-approved generic priced at $40 per person per year is comparable in price to daily HIV-prevention pills.
More context
On Monday, the FDA approved a cheaper lenacapavir generic, a twice-yearly HIV-prevention shot that may now move closer to low-income markets. Dr. Reddy's said the approval was granted under the FDA's President's Emergency Plan for AIDS Relief program. Lenacapavir was developed by Gilead Sciences and approved in June 2025 after large clinical trials found it more than 99.9 percent effective. Carmen Perez-Casas, Unitaid's senior strategy lead for HIV and pandemic preparedness, said the FDA-approved generic would cost $40 per person per year, comparable to daily HIV-prevention pills. She said lenacapavir had shortened the gap between breakthrough medicines and access in poorer countries to little more than a year. Unitaid said more than 125,000 people in 10 early-adopter African countries have already started Gilead's version. The twice-yearly injection can be more effective than daily PrEP pills, which must be taken consistently.
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Reporting
- France 24 — US approves cheap generic of breakthrough HIV shot for poorer countries
- France 24 (with Agence France-Presse) — US approves cheap version of breakthrough HIV prevention shot: manufacturer
- Radio France Internationale — US approves cheap version of breakthrough HIV ...
- wtnh.com — Approval of a cheap version of HIV-prevention shot ...
Verifier’s note
WTNH reports the approval and its promise of wider access, while France 24 and RFI also report the FDA approval of a low-cost lenacapavir version for poorer countries. These reports were published the same day as the proposed event and do not contradict its central claim.