Washington (United States) (AFP) – The American Medicines Agency (FDA) on Monday approved a low-cost generic version of a preventive treatment against HIV whose effectiveness approaches 100%, intended for low- and middle-income countries, “an extraordinary advance for global health”, welcomed the Unitaid organization.

Published on: 02/11/2026 - 17:49

This approval was announced by Dr Reddy's Laboratories, the Indian manufacturer of the generic version of lenacapavir, and by Unitaid, an international organization whose action aims to facilitate access to medicines.

The treatment will be available at a price of $40 per person per year, in 120 low- and middle-income countries, under an agreement announced in September 2025. The first drugs are expected "before the end of the year, with greater availability in 2027", Unitaid indicates on its website.

This treatment consists of two annual injections and reduces the risk of HIV transmission by 99.9%, a small revolution in the field of drugs known as "pre-exposure prophylaxis", or "PrEP".

Previously, these treatments, taken by people who are not infected but considered at risk, required taking one tablet daily.

“This is an extraordinary breakthrough for global health. For too long, people in low- and middle-income countries have had to wait ten years or more to access revolutionary drugs already available elsewhere. With lenacapavir, we have reduced this delay to just over a year,” Carmen Pérez-Casas, senior manager of Unitaid's HIV strategy, told AFP.

“This is a moment of immense pride for all of us at Dr. Reddy’s,” said Deepak Sapra, manager at the Indian laboratory in a statement.

“Developing and manufacturing a complex injectable like lenacapavir at an affordable cost requires significant scientific capabilities and solid industrial know-how to meet an urgent need for access to treatment,” he added.

Asked by AFP, the FDA did not react immediately.

Lenacapavir, first manufactured by the American laboratory Gilead, was approved in June 2025 but its very high price remained prohibitive.

- Hope -

This new treatment thus fuels the hope of reducing the number of new HIV infections, particularly in developing countries.

“But the real success is yet to come,” warned Carmen Pérez-Casas of Unitaid.

“An estimated 1.2 million people contracted HIV last year, even though we now have a drug that provides close to 100% protection with just two injections per year,” she continued.

“Unitaid is already working with governments and its partners to support the deployment of lenacapavir under the leadership of the countries,” said the manager.

“Even before generics are available, more than 125,000 people in 10 pioneering African countries have already started distributing Gilead's lenacapavir treatment,” Unitaid said in its press release.

At the end of February, Kenya had already started administering its first doses of lenacapavir in a working-class neighborhood in the capital Nairobi.

UNAIDS, the United Nations agency responsible for combating this disease, warned in June that massive cuts in international aid were compromising the fight against HIV, with a decline in screening, access to preventive treatments and the distribution of condoms.

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© 2026 AFP

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