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FDA Approves Generic HIV Prevention Shot, Widening Access
· Confirmed
In Short: The US Food and Drug Administration has approved the first generic version of lenacapavir, developed by Dr Reddy’s Laboratories, to prevent HIV, aiming to widen access in lower-income countries.
The US Food and Drug Administration (FDA) has approved the first generic version of lenacapavir, the highly effective twice-yearly injection to prevent HIV, developed by Dr Reddy’s Laboratories based in India. The approval marks a significant step in expanding access to the medication in lower-income countries.
The generic version of lenacapavir, which was originally developed by US pharmaceutical company Gilead Sciences, received tentative FDA approval in October 2024, just 16 months after Gilead’s product was approved. This rapid approval process is attributed to prioritizing access from the start, as noted by CHAI CEO Dr Neil Buddy Shah.
The annual cost per person for the generic version will be $40, comparable to daily tablets. This price point is expected to make the drug more accessible in low- and middle-income countries, where the high cost of existing treatments has limited availability.
The generic manufacturer, Dr Reddy’s Laboratories, received financial, technical, and regulatory support from Unitaid, Wits RHI, and the Clinton Health Access Initiative (CHAI) to accelerate the development of the generic. This collaboration aims to ensure equitable access and impact in countries where health systems are ready to deliver new prevention options.
Dr Carolyn Amole, who heads the HIV program at the Clinton Health Access Initiative, said affordable generic availability could help expand access to pre-exposure prophylaxis (PrEP), preventive medication taken by people at risk of HIV before exposure to the virus.
The generic version is expected to become available in some countries within weeks, although access may take longer in places where separate regulatory approvals are required. The first supplies are expected to reach countries before the end of 2026, with wider availability planned for 2027.
“Generic lenacapavir has the potential to transform HIV prevention, and this is a significant milestone, but an affordable drug alone is not enough,” Saiqa Mullick, Ph.D., a professor and director of implementation science at Wits RHI, said in a release.
The approval is expected to make the medication more affordable and speed up its availability in countries where access to HIV prevention options remains a challenge.
More than 125,000 people in 10 African countries have already started Gilead’s version, according to Unitaid. The generic version is intended for adults and adolescents weighing at least 35 kg who are at risk of sexually acquired HIV-1.
Gilead Sciences granted royalty-free licenses to six generic makers in October 2024, but those licenses limit sales to the 120 covered countries. The company shared the urgency of expanding access to lenacapavir and believed its licensing arrangements offered a sustainable route to reaching communities most affected by HIV.
The development could significantly improve access to HIV prevention, particularly in countries where the high cost of existing treatments has limited availability.
The FDA approval of the generic version of lenacapavir is a critical step towards expanding access to HIV prevention in lower-income countries, but the challenge now lies in ensuring widespread availability and securing funds to support its distribution.
What this adds
The approval process for the generic version was notably faster than usual, reflecting a new standard for global health access.
The drug's effectiveness and reduced cost could significantly impact HIV prevention efforts in low- and middle-income countries.
The collaboration between various global health organizations and generic manufacturers highlights a coordinated effort to address the HIV epidemic.
Background
The FDA has approved a generic version of the HIV prevention drug lenacapavir, marking a significant step in expanding access to the medication in lower-income countries.
The US Food and Drug Administration has approved the first generic version of lenacapavir, developed by Dr Reddy’s Laboratories, to prevent HIV, aiming to widen access in lower-income countries.
What's confirmed
- The agreement, signed in October 2024, limits the sale of the generics to 120 high-incidence, resource-limited countries.
- The company, one of the world’s largest generic drugmakers, plans to start shipping the medicine next month as part of an effort propelled, in part, by several global health organizations to ensure the drug becomes available in lower-income countries as quickly as possible.
- “Unitaid’s early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries,” said Dr. Philippe Duneton, Unitaid executive director.
- Dr Reddy received “financial, technical, and regulatory support” from Unitaid, Wits RHI, and the Clinton Health Access Initiative (CHAI) to accelerate the development of the generic.
- Washington (US), Nov 3 : The US Food and Drug Administration (FDA) has granted approval to an India-made generic version of lenacapavir, the world’s only twice-yearly injection for HIV prevention, in a major step towards expanding affordable access to the drug across 120 low- and middle-income countries.
- Reddy’s Laboratories under an agreement facilitated by Unitaid, the Clinton Health Access Initiative and Wits RHI, an African health research institute.
- Reddy's generic injection is expected to cost US$40 per person annually across the 120 eligible countries, with initial supplies expected by the end of 2026.
- The FDA has granted tentative approval to the first generic version of injectable lenacapavir, a twice-yearly HIV pre-exposure prophylaxis (PrEP) option, according to a news release from Unitaid, one of the healthcare organizations involved.
- With an affordable, high-quality generic medication now available, “we could help to scale this to the 20 million people around the world who need PrEP,” prescription medicine taken by people at risk of HIV before being exposed to the virus, said Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, a global health organization.
- Lenacapavir was originally developed by US pharmaceutical company Gilead Sciences and received FDA approval for HIV prevention in June 2025 after demonstrating more than 99.9 per cent effectiveness in large clinical trials.
What's still developing
- German startup Isar Aerospace on Sunday said it would rapidly expand satellite deployments after the first orbital launch of its Spectrum rocket from Arctic Norway, a milestone for Europe’s efforts to secure independent access to space.
- Under the agreement, India will cut tariffs on 80–85% of goods coming from these countries to zero, while Indian exporters will get duty-free access to 99% of goods in EFTA markets.
- Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis.
- The medicine has been developed for both HIV treatment and prevention, although the formulations and dosing schedules differ depending on its intended use.
- One of the major challenges in HIV prevention is ensuring that people can consistently follow the recommended medication schedule.
- This prevents HIV from multiplying and spreading in the body.
- What Two New Trials Found Home Health News Us Fda Approves Dr Reddys Generic Hiv Prevention Shot What Cheaper Lenacapavir Means For India Other Countries Health and Me Health and Me is a premium website with content written and curated to function as a handbook for all Health concerns.
- This can be especially helpful for people who may miss daily doses because of busy lives, stigma, travel, or difficulty accessing medicines regularly.