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The US Food and Drug Administration (FDA) has granted tentative approval to Indian pharmaceutical company Dr. Reddy's Laboratories for its generic version of lenacapavir. This drug is a breakthrough HIV prevention injection that needs to be administered just twice a year. This approval is granted under the US President's Emergency Plan for AIDS Relief (PEPFAR) and is an important step towards making HIV prevention more affordable and accessible across low- and middle-income countries. This generic injection is made for adults and adolescents weighing at least 35 kg who are at risk of sexually acquired HIV-1.
Under an existing agreement, the injection is expected to be available at $40 per person per year across 120 countries covered by the voluntary licence granted by US-based Gilead Sciences. The first supplies are expected to reach countries before the end of 2026, with wider availability planned for 2027.
What Is Lenacapavir And How Does It Prevent HIV?
Lenacapavir is a long-acting antiviral medicine originally developed by Gilead Sciences. It belongs to a class of medicines called HIV-1 capsid inhibitors. Lenacapavir works at multiple stages to prevent HIV from multiplying and spreading in the body, which is unlike several other existing antiviral medicines that target a single stage of the virus's life cycle.
The drug has been developed for both HIV treatment and prevention, although the formulations and dosage schedules differ depending on its use. For HIV prevention, it is administered as an injection twice a year, making it a convenient option for people who may struggle with daily preventive medication. The World Health Organization (WHO) has also recommended twice-yearly injectable lenacapavir in its HIV prevention guidelines. The medicine has been recognised as a major scientific development, with the journal Science naming it the 2024 'Breakthrough of the Year'.
Why Is The US FDA Approval Important?
The FDA's tentative approval is an important milestone because it allows Dr. Reddy's to go ahead with supplying an affordable generic version of the injection in eligible countries. The development follows a voluntary licensing agreement granted by Gilead Sciences to Dr. Reddy's in October 2024. In September 2025, Dr. Reddy's entered into an agreement with Unitaid, the Wits Reproductive Health and HIV Institute (Wits RHI), and the Clinton Health Access Initiative (CHAI) to support product development, regulatory processes and wider access.
Dr Neil Buddy Shah, CEO of CHAI, highlighted the importance of making HIV prevention easier to follow. "For someone at risk of HIV, taking a pill every day to prevent a disease they don't have is a hard thing to ask. Two injections a year, of a product that is almost 100% effective at preventing HIV, changes that entirely," he said.
He also pointed out that more than 1,25,000 people in Africa have already started using lenacapavir, adding that the generic approval could bring the medicine within reach of millions more.
How Can A Twice-Yearly Injection Help Prevent HIV?
One of the biggest challenges in HIV prevention is ensuring that people can consistently follow preventive treatment. Pre-exposure prophylaxis (PrEP) involves taking medication before potential exposure to HIV to reduce the risk of infection. Daily oral PrEP is an effective prevention option, but taking a pill every day can be difficult for some people because of lifestyle, access, privacy concerns or challenges with maintaining a routine. A twice-yearly injection could help address some of these barriers.
- Fewer doses: Instead of taking a preventive pill every day, people can receive two injections annually, reducing the need for frequent medication.
- Convenience: People who have difficulty maintaining a daily medication schedule may find long-acting injections easier to follow.
- Higher privacy: Some individuals may prefer receiving an injection twice a year rather than keeping daily HIV prevention medication at home.
- Better access: The planned $40 annual price could make this prevention option more accessible in countries with limited healthcare resources.
- Additional prevention: Lenacapavir offers another option for people who may not prefer or be able to use daily oral PrEP.
However, HIV-negative status must be confirmed before starting lenacapavir and before every subsequent injection. The medicine is intended for HIV prevention and does not replace other measures to reduce the risk of sexually transmitted infections.
Deepak Sapra, Chief Executive Officer, API and Services, Dr. Reddy's Laboratories Ltd., said, "This is a moment of immense pride for all of us at Dr. Reddy's. Developing and manufacturing a complex long-acting injectable like lenacapavir at an affordable price required strong scientific capabilities and manufacturing expertise to address an urgent access need. The U.S. FDA approval validates that work and brings us a significant step closer to making this twice-yearly HIV prevention option available to people across low- and middle-income countries."
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