In the fight against AIDS, U.S. authorities have approved an affordable version of a pre-exposure prophylaxis shot that protects against HIV infection. The U.S. Food and Drug Administration granted the provisional approval to a generic form of the prophylactic agent Lenacapavir, produced by the Indian pharmaceutical giant Dr. Reddy’s, on Monday, according to Dr. Reddy’s and the international health organization Unitaid.
The injections, which must be given twice a year to guard against HIV, are slated to be available in 120 countries for just $40 per person per year. Unitaid representative Carmen Pérez Casas described this in an interview with the news agency AFP as an “extraordinary milestone for global health.”
In developing and lower-income countries, people would have had to wait ten years or even longer for medications already available elsewhere to reach them, Pérez Casas said. “With Lenacapavir, we have reduced that gap to a little over a year.”
Lenacapavir was approved in June 2025
Lenacapavir was developed by the U.S. pharma company Gilead Sciences and received approval in June 2025. The medication demonstrably lowers the risk of HIV transmission by more than 99.9 percent, effectively acting like a vaccine against AIDS.
However, the agent is very expensive: in the United States, it costs about $28,000 per person per year. That price tag previously stood in the way of broad rollout in poorer countries.
Drugs to prevent HIV infections have been used for more than a decade. In 2012, tablets for the so-called pre-exposure prophylaxis (PrEP) gained approval in the United States. However, these pills must be taken daily to be effective. In 2021, the active ingredient Cabotegravir was approved, which must be injected every two months.
Distribution of the drug is the next challenge
With Lenacapavir, the number of injections needed per year is reduced even further. Unitaid representative Pérez Casas said on Monday that after the approval of the generic, the next challenge is getting the drug to people in poorer countries.
“Last year, it is estimated that 1.2 million people became infected with HIV, even though we have a drug that offers almost 100 percent protection with only two injections per year,” she said. “Demand is high, and we cannot afford to lose momentum now.”
Estimates indicate that over the past four decades, more than 40 million people worldwide have died from the consequences of HIV/AIDS. Source: AFP.
