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FDA Approves Generic HIV Prevention Shot, Paving Way for Global Access
· Confirmed
In Short: The United States Food and Drug Administration (FDA) has granted tentative approval to a cheaper generic version of a twice-yearly HIV prevention injection, developed by Dr. Reddy's Laboratories, paving the way for wider access to the drug in 120 low- and middle-income countries.
The United States Food and Drug Administration (FDA) has granted tentative approval to a cheaper generic version of a twice-yearly HIV prevention injection, developed by Dr. Reddy's Laboratories, paving the way for wider access to the drug in 120 low- and middle-income countries. The generic version of lenacapavir, originally developed by Gilead Sciences, is expected to cost about $40 per person annually, matching the current cost of daily HIV-prevention pills.
Lenacapavir received FDA approval for HIV prevention in June 2025 after demonstrating more than 99.9% effectiveness in large clinical trials. The drug is given as an injection only twice a year, making HIV prevention easier for people who find it difficult to take a daily pill.
According to Unitaid, more than 125,000 people across 10 early-adopter African countries had already started using Gilead’s lenacapavir before the generic version became available. The partnership between Unitaid, the Clinton Health Access Initiative, and Wits RHI, an African health research institute, has helped shorten the time between scientific breakthroughs and access to essential medicines.
CHAI CEO Dr. Neil Buddy Shah emphasized the importance of prioritizing access from the start, stating, '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. This should be the new standard for global health.'
A Gilead spokesperson said 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 agreement signed in October 2024 limits the sale of the generics to 120 high-incidence, resource-limited countries.
The FDA granted tentative approval to the Indian generic under a longstanding mechanism designed to ensure the quality of HIV-related medicines supplied to other countries through US government programs. This decision is crucial for people who may miss daily doses due to busy lives, stigma, travel, or difficulty accessing medicines regularly.
What this adds
The FDA's tentative approval is a significant step in expanding access to the medication in lower-income countries, as previously reported by WarpBeat.
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 FDA 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 United States Food and Drug Administration (FDA) has granted tentative approval to a cheaper generic version of a twice-yearly HIV prevention injection, paving the way for wider access to the drug in 120 low- and middle-income countries.
- Unitaid Executive Director Philippe Duneton also said the partnership was helping shorten the time between scientific breakthroughs and access to essential medicines.
- 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.
- The work was supported through an agreement involving Unitaid, the Clinton Health Access Initiative and Wits RHI, an African health research institute.
What's still developing
- The company combined lenacapavir's prevention and treatment uses in a single application, which allowed it to request priority review, CHAI said.
- The branded version, called Yeztugo, is made by Gilead Sciences and cannot be replaced by the generic in the US market.
- The manufacturer and organisations that supported the development of the drug’s generic version announced the news on Monday, November 2, 2026, morning.
- Two major studies involving people at high risk of HIV found that the injection nearly eliminated new infections, showing its potential as a prevention option.