Health · Pharma & Biotech · 44 mins ago
FDA approves low-cost generic HIV prevention injection
The FDA approved a generic version of lenacapavir, an HIV prevention drug made by India’s Dr. Reddy’s Laboratories.
The injection is given twice a year and offers nearly complete protection against HIV, unlike preventive pills that must be taken daily.
The generic is expected to cost $40 per person each year in 120 low- and middle-income countries.
Less frequent doses may make prevention easier for people who struggle to take a pill every day.
The US approval is tentative because Gilead’s brand-name version remains protected by patent, so the generic cannot be sold in the United States.
The first supplies are expected by year-end, with wider availability expected in 2027.
The US Food and Drug Administration approved the first generic version of lenacapavir, a long-acting injection used to prevent HIV.
The generic was developed by India-based Dr. Reddy’s Laboratories and is intended for low- and middle-income countries.
It is expected to cost $40 per person per year and is covered by agreements for sale in 120 countries.
Lenacapavir is given twice a year, unlike daily preventive pills.
Initial supplies are expected by the end of 2026, with wider availability expected in 2027, according to Unitaid.
- Who
- The US Food and Drug Administration approved the generic, developed by Dr. Reddy’s Laboratories.
- What
- The first generic version of lenacapavir, a twice-yearly HIV prevention injection, was approved.
- When
- November 2, 2026.
- Where
- It is intended for 120 low- and middle-income countries.
- Why
- To help make HIV prevention more affordable and accessible in countries with limited resources.
This story does not have two clearly opposing sides.
Gilead signed a non-exclusive, royalty-free licensing agreement with six generic manufacturers, including Dr. Reddy’s.
The original Gilead lenacapavir product was approved, according to franceinfo.
The FDA approved the first generic version of lenacapavir.
Unitaid expects the first generic supplies to reach countries.
Unitaid expects wider availability.
- Drug
- Lenacapavir
- Generic maker
- Dr. Reddy’s Laboratories, based in India
- Expected annual price
- $40 per person
- Eligible countries
- 120 low- and middle-income countries
- Dosing
- Two injections per year
5 sources
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Aprobación de versión barata de fármaco contra VIH da esperanzas a países de ingreso bajo
FDA Approves First Generic of HIV Prevention Drug, Lenacapavir
What people are saying
With lenacapavir, tenemos mucha más esperanza.
Getting a generic approved just 16 months after the originator approval for prevention, rather than a decade later, shows what’s possible when we prioritize access from the start.
Countries need health systems that are ready to deliver new prevention options, providers who are confident in offering them, and communities that are engaged as partners in their introduction and scale-up.
Compartimos el sentido de urgencia en torno a ampliar el acceso a lenacapavir para la prevención del VIH.