India-made HIV Prevention Shot Gets US FDA Approval

An India-developed generic version of a long-acting injectable drug for HIV prevention has received approval from the US Food and Drug Administration (FDA), marking a significant step towards making one of the most promising advances in HIV prevention more affordable and accessible in resource-limited countries.

Developed by Hyderabad-based Dr Reddy’s Laboratories, the generic formulation is based on lenacapavir, originally developed by US pharmaceutical company Gilead Sciences. Unlike conventional pre-exposure prophylaxis (PrEP), which generally requires people at risk of HIV infection to take a pill every day, the injectable formulation requires administration only once every six months.

The medicine is expected to be available at around $40 (approximately Rs 3,400) per person annually in 120 low- and middle-income countries. Initial supplies are expected to reach eligible countries by the end of the year, according to Unitaid, a global health agency affiliated with the World Health Organization (WHO).

The development could address one of the longstanding challenges in HIV prevention: ensuring that people at risk can consistently follow preventive medication schedules. Daily pills can be difficult to maintain, particularly for those facing stigma, concerns about disclosure or limited access to healthcare services.

Neil Buddy Shah, chief executive officer of the Clinton Health Access Initiative (CHAI), which supported the development of the generic, said taking a daily pill to prevent an infection in someone who is otherwise healthy can be challenging.

“Two injections a year, of a product that is almost 100% effective at preventing HIV, changes that entirely,” he said.

Lenacapavir belongs to a class of medicines that interfere with HIV's ability to replicate. When used as PrEP, it prevents the virus from establishing an infection in people who are HIV-negative but face a risk of exposure.

Clinical trials have demonstrated near-complete protection against HIV acquisition in the populations studied, making it an important addition to existing preventive approaches. Its six-month dosing schedule could particularly benefit people who find it difficult to take daily medication, including those who may avoid carrying pills because of the stigma associated with HIV.

The drug was initially developed by Gilead and has also been used since 2022 to treat certain people with multidrug-resistant HIV. Its use for prevention represents a separate application, intended for HIV-negative individuals.

To expand access beyond wealthier markets, Gilead entered into royalty-free voluntary licensing agreements in 2024 with six generic manufacturers, allowing production for eligible low- and middle-income countries. The Dr Reddy's formulation is not intended for sale in the US market under this arrangement.

Despite the regulatory milestone and proposed low price, ensuring that the injections reach people who need them remains a major challenge. Approval does not automatically translate into availability, particularly in countries where public health budgets, procurement systems and healthcare infrastructure are constrained.

Rachel Vreeman, dean for Global Health at the Icahn School of Medicine at Mount Sinai, cautioned that affordable medicines still require financing, trained personnel and systems for delivery.

“Even a cheap drug needs someone to pay for it, and for staff and systems to deliver it,” she told CIDRAP News.

She said large-scale procurement commitments from governments and international agencies, including the Global Fund to Fight AIDS, Tuberculosis and Malaria, would be critical to ensuring supplies reach eligible populations.

The need is pressing. According to WHO estimates, around 41 million people were living with HIV worldwide in 2025, while approximately 570,000 died from HIV-related illnesses in the previous year. Sub-Saharan Africa continues to account for a substantial share of new infections, with about half of the global total occurring in the region.

For countries such as India, the generic formulation presents an opportunity to expand access to newer prevention technologies at a potentially lower cost. However, its eventual impact will depend on national regulatory processes, procurement decisions, reliable supplies and integration into existing HIV prevention programmes.

The larger challenge is to ensure that a breakthrough in drug development translates into a practical preventive option for people who remain vulnerable to HIV infection.