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FDA Approves Generic HIV Prevention Shot, Expanding Global Reach
· Confirmed
In Short: The FDA has granted tentative approval to a cheaper generic version of a twice-yearly HIV prevention injection, developed by Dr. Reddy's Laboratories, for wider access 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. This approval is a significant step in expanding access to the medication in lower-income countries, where the high cost of existing treatments has been a major obstacle.
Lenacapavir, originally developed by US pharmaceutical company Gilead Sciences, received FDA approval for HIV prevention in June 2025 after demonstrating more than 99.9% effectiveness in large clinical trials. In clinical trials, 99.9% of participants who received lenacapavir remained HIV-negative, CBS News reported when the FDA approved Yeztugo. Gilead sells that shot in the U.S. As Yeztugo, and it launched at a list price of $28,218 a year, Drugs.com reported at the time. Its annual list price in the United States is approximately $28,000.
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 branded version, called Yeztugo, is made by Gilead Sciences and cannot be replaced by the generic in the US market. The generic is made by India-based Dr. Reddy’s Laboratories, and Unitaid announced the approval on November 2.
The FDA's approval of the generic version of lenacapavir is expected to make the medication more affordable and speed up its availability in countries where access to HIV prevention options remains a challenge. The medicine is expected to cost about $40 per person for a year, which is close to the yearly cost of daily HIV-prevention pills. The annual cost per person will be $40, comparable to daily tablets.
The work was supported through an agreement involving Unitaid, the Clinton Health Access Initiative, and Wits RHI, an African health research institute. Gilead granted royalty-free licenses to six generic makers in October 2024 but those licenses limit sales to the 120 covered 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.
The development could significantly improve access to HIV prevention, particularly in countries where the high cost of existing treatments has limited availability. 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. The medicine is expected to cost around USD 40 per person annually in the countries where it will be available, matching the current cost of daily HIV-prevention pills.
Lenacapavir works as PrEP, which stands for pre-exposure prophylaxis. The injection is expected to cost around USD 40 per person annually in the countries where it will be available, matching the current cost of daily HIV-prevention pills. This decision is important because the medicine 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 company combined lenacapavir's prevention and treatment uses in a single application, which allowed it to request priority review, CHAI said. 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.
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 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.
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.
- 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.
- “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,” said CHAI CEO Dr Neil Buddy Shah.
- The FDA has granted tentative approval to Dr. Reddy's Laboratories for the first generic version of injectable lenacapavir, the twice-yearly HIV prevention shot.
- 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.
- “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,” she said.
What's still developing
- CHAI describes it as the FDA's standard designation for generics while the originator product remains under patent.
- Last year, the company signed royalty-free licensing agreements with six generic manufacturers.
- The agreement, signed in October 2024, limits the sale of the generics to 120 high-incidence, resource-limited countries.
- She said the aim would be to reach around 20 million people globally who need PrEP, adding that wider access could help bring the HIV epidemic under control.
- 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 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 programmes.
- 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.
- 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.
- “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 the release.