FDA Tentatively Approves First Generic Long-Acting Injectable for HIV Prevention: $40 Per Person Per Year Across 120 Countries
The U.S. Food and Drug Administration (FDA) has granted tentative approval to the first generic long-acting injectable lenacapavir for HIV prevention, just 16 months after the originator product was approved in June 2025. Dr. Reddy's Laboratories, which developed the generic, and its supporting partners announced the decision in Geneva on November 2, calling it one of the fastest timelines to approval for a major HIV innovation to date.
Lenacapavir requires only two injections a year and is almost 100% effective at preventing HIV. Under the existing partnership agreement, Dr. Reddy's lenacapavir injection will be available at $40 per person per year for the 120 low- and middle-income countries included in Gilead's voluntary license. First supplies are expected to reach countries before the end of 2026, with broader availability in 2027.
The approval follows a landmark pricing agreement announced in September 2025 between Unitaid, Wits RHI, the Clinton Health Access Initiative (CHAI), and Dr. Reddy's, which combined an early pricing commitment with financial, technical and regulatory support. Even before generic availability, over 125,000 people in 10 early adopter African countries have already started Gilead's lenacapavir.
"For someone at risk of HIV, taking a pill every day to prevent a disease they don't have is a hard thing to ask. Two injections a year, of a product that is almost 100% effective at preventing HIV, changes that entirely," said Dr. Neil Buddy Shah, CEO of CHAI. Dr. Philippe Duneton, Executive Director of Unitaid, said the organization's early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries.
Tentative approval is the FDA's standard designation for generics while the originator remains under patent; it means the drug has met the agency's safety, efficacy and quality standards and enables procurement by the U.S. government. The partners said the next step is turning approval into country-level introduction and community engagement. (Source: Clinton Health Access Initiative)
Source: Clinton Health Access Initiative
Published by GSM · USA (original Chinese edition)
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