The twice-yearly lenacapavir shot, which demonstrated more than 99.9 per cent effectiveness in clinical trials, is expected to make long-acting HIV prevention more affordable and accessible across low- and middle-income countries.

The United States Food and Drug Administration (FDA) has granted tentative approval to a low-cost generic version of lenacapavir, a breakthrough HIV prevention injection that could significantly expand access to HIV prevention services in developing countries.

The generic version, manufactured by Indian pharmaceutical company Dr. Reddy’s Laboratories, is expected to be available for approximately $40 per person annually in 120 countries under a pricing agreement announced in September 2025.

The development was announced by Dr. Reddy’s and Unitaid, a global health initiative working to improve access to affordable medicines and medical innovations.

Lenacapavir is administered through an injection twice a year and offers an alternative to daily oral medication for people seeking protection against HIV infection.

The original drug was developed by US pharmaceutical giant Gilead Sciences and received approval in June 2025 after clinical trials demonstrated more than 99.9 per cent effectiveness in preventing HIV infection.

The introduction of an affordable generic version is expected to remove one of the biggest barriers to accessing the treatment: its high price.

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In the United States, the branded version costs approximately $28,000 annually, although insurance coverage can significantly reduce the amount paid by individual patients.

Under the agreement involving Unitaid, South Africa-based Wits RHI, the Clinton Health Access Initiative and Dr. Reddy’s Laboratories, the generic version will be supplied at a fraction of that cost to eligible countries.

Unitaid's senior strategy lead for HIV and pandemic preparedness, Carmen Perez-Casas, described the FDA's decision as a major breakthrough for global health.

"This is an extraordinary milestone for global health," she told AFP.

She noted that people in low- and middle-income countries have historically waited many years before gaining access to innovative medicines already available in wealthier nations.

According to Perez-Casas, the introduction of generic lenacapavir has dramatically shortened that waiting period.

"With lenacapavir, we've reduced that gap to little more than a year," she said, describing the $40 annual price as a remarkable achievement comparable to the cost of daily HIV prevention pills.

Unlike traditional pre-exposure prophylaxis (PrEP), which generally requires people to take medication every day, lenacapavir offers protection through two injections annually.

Although the injection has sometimes been compared to a vaccine because of how infrequently it is administered, it does not train the immune system to recognise and fight HIV. Instead, it works as a long-acting antiretroviral medicine that prevents the virus from establishing an infection.

Daily PrEP pills have been available since receiving their first US approval in 2012. However, their effectiveness depends heavily on consistent use, making long-acting injections an important alternative for people who struggle with daily medication routines.

The breakthrough is particularly significant given the global impact of HIV, which has claimed more than 40 million lives over the past four decades.

To accelerate access to affordable treatment, Gilead Sciences granted voluntary licensing agreements to six generic drug manufacturers, including Dr. Reddy’s, in late 2024.

Even before generic supplies become widely available, more than 125,000 people across 10 African countries participating in early adoption programmes have already started receiving Gilead's lenacapavir, according to Unitaid.

Dr. Reddy’s also welcomed the FDA decision, describing it as a major achievement for the company and its efforts to expand access to affordable healthcare.

Deepak Sapra, the company's Chief Executive Officer of Pharmaceutical Services and Active Pharmaceutical Ingredients, said the development was a moment of immense pride for the pharmaceutical manufacturer.

The FDA's decision was granted through a tentative approval process that allows generic manufacturers to rely on existing clinical and scientific data under an accelerated regulatory pathway.

The approval marks an important step towards making long-acting HIV prevention more accessible, particularly in regions where the cost of innovative medicines has historically placed them beyond the reach of many people.

With an annual price of $40, the generic injection could help more people access effective HIV prevention without the burden of taking daily medication.