Washington (United States) (AFP) - The US Food and Drug Administration (FDA) on Monday approved a low-cost version of an injection to prevent human immunodeficiency virus (HIV) that is given twice a year, bringing this pioneering drug closer to markets in low-income countries.

Published on: 02/11/2026 - 19:29

This initial approval was announced by Dr. Reddy's Laboratories, an Indian company that manufactures the generic (non-commercial) version of lenacapavir, and the global health initiative Unitaid.

This generic version will be available at a cost of $40 per person per year in 120 countries, under a pricing agreement announced in September 2025 between Unitaid, the Wits Research Institute for Health in Africa (Wits RHI), the Clinton Access to Health Initiative (CHAI), and Dr. Ready's.

The drug "Lenacapavir" was originally developed by the American pharmaceutical company "Gilead Sciences", and was approved in June 2025 after proving an effectiveness exceeding 99.9% in large-scale clinical trials.

In a statement to Agence France-Presse, Carmen Pérez-Casas, chief strategy officer for HIV and epidemic preparedness at UNITAID, said: “This is an extraordinary achievement for global health. For too long, people in low- and middle-income countries have had to wait a decade or more to obtain pioneering medicines that were available elsewhere.”

She added, "With lenacapavir, we have succeeded in reducing this gap to just over one year. Providing a generic version approved by the US Food and Drug Administration at $40 per person per year, a price comparable to the cost of daily pills for HIV prevention, is a remarkable achievement."

This twice-yearly injectable drug, which is similar to a vaccine in terms of the method of administration, although it does not work to train the immune system, may represent a more effective means of providing “pre-exposure prophylaxis” (PrEP) to the virus compared to daily pills, noting that the pills received US approval for the first time in 2012, but their effectiveness depends entirely on commitment to taking them regularly.

However, the high cost of lenacapavir, which amounts to about $28,000 annually in the United States, constituted a major obstacle to its transformation into an essential tool in combating this disease, which has claimed the lives of more than 40 million people over four decades.

In late 2024, Gilead granted voluntary licenses to produce lenacapavir to six generic drug manufacturers, including Dr. Redis.

A statement issued by the "United" organization stated that even before the availability of generic versions of the drug "lenacapavir" produced by "Gilead", more than 125,000 people in 10 African countries that were among the first countries to adopt the drug had already begun using it.

Deepak Sapra, CEO of Pharmaceutical Services and Active Pharmaceutical Ingredients at Dr. Reddy's, said in a statement, "This is a moment of great pride for all of us at Dr. Reddy's."

"United" explained that the generic version of the drug has received "initial approval" from the US Food and Drug Administration, under the process of accelerating procedures that allows applicants to benefit from the data already available.

© 2026 AFP

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