November 03, 2026

FDA clears generic twice-yearly HIV injection for developing nations

Initial supplies are likely to reach selected countries within weeks

FDA clears generic twice-yearly HIV injection for developing nations
A logo is pictured outside a building of the United Nations AIDS agency (UNAIDS) in Geneva, Switzerland, Apr 6, 2021. Picture taken Apr 6, 2021. REUTERS/Denis Balibouse

bdnews24.com News Service

Published : 03 Nov 2026, 04:26 PM

Updated : 03 Nov 2026, 04:26 PM

The US Food and Drug Administration has granted tentative approval for a generic version of the world's only twice-yearly injectable HIV prevention drug, lenacapavir, opening a pathway to distribute affordable preventative care across 120 low- and middle-income countries.

Global health agencies project that the generic treatment will cost $40 per person annually in designated recipient nations across sub-Saharan Africa, Asia, and Latin America, The Independent reports.

This matches the current price of daily oral pre-exposure prophylaxis (PrEP) tablets while offering a far more convenient dosing schedule. Clinical trials demonstrated that the biannual injections virtually eliminated new HIV infections among high-risk trial participants.

India-based Dr Reddy’s Laboratories developed the generic medication through an international consortium involving Unitaid, the Clinton Health Access Initiative, and South African research institute Wits RHI.

Based on details published by The Independent, the brand-name version, Yeztugo, carries an annual US list price of $28,218 and remains under active patent protection, which prevents generic sales within the American market.

Health experts emphasize that scaling distribution to the 20 million people needing PrEP globally could significantly curb HIV transmission and reduce AIDS-related fatalities.

Patients must undergo rapid HIV testing before each shot, as administering lenacapavir to individuals with undiagnosed infections risks creating drug-resistant virus strains. Initial distribution in select recipient countries is scheduled to begin within weeks.

Related Stories