By Julián Kaper
En esta noticia
The US Food and Drug Administration (FDA) approved a generic version of an HIV preventive treatment on Monday. It will be low-cost and given as a twice-yearly injection, bringing this breakthrough drug closer to the market in low-income countries.
The approval from U.S. authorities was announced by Dr. Reddy’s Laboratories, the Indian drugmaker that manufactures the generic version of lenacapavir, and by Unitaid, an international initiative to supply medicines in low- and middle-income countries, reported DW and Noticias Argentinas learned.
What the approved HIV treatment is like and how much it costs
The treatment will cost $40 a year per patient and will be available in 120 countries, thanks to a pricing agreement announced in September 2025 between Dr. Reddy’s and Unitaid, the African health research institute Wits RHI, and the Clinton Health Access Initiative (CHAI).
This treatment of two annual injections can cut the risk of HIV transmission by 99.9%, a small revolution in the field of medicine known as pre-exposure prophylaxis, or PrEP. Other preventive treatments require taking a pill every day.
The importance of this treatment, according to its developers
“This is a moment of immense pride for all of us at Dr. Reddy’s,” Deepak Sapra, the company’s chief executive of Pharmaceutical Services, said in a statement. He added: “Developing and manufacturing a complex long-acting injectable like lenacapavir at an affordable price required strong scientific capabilities and manufacturing expertise to meet an urgent need for access.”
U.S. authorities approved lenacapavir, developed by Gilead, in June 2025. But its high cost — about $28,000 a year in the United States, though insurance plans apply discounts — was a major obstacle to turning it into a decisive tool against a disease that has killed more than 40 million people over four decades.
At the end of 2024, Gilead licensed six pharmaceutical companies, including Dr. Reddy’s, to make generic versions of lenacapavir. Even before the generics were available, more than 125,000 people in 10 African countries that were early adopters of the treatment had already started receiving lenacapavir.
The FDA’s official announcement in this link.