Generic lenacapavir HIV prevention gets FDA tentative approval
November 3, 2026
Generic lenacapavir HIV prevention took a regulatory step on 2 November 2026, when Dr. Reddy’s announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for its long-acting injectable lenacapavir for pre-exposure prophylaxis (PrEP) in adults and adolescents weighing at least 77 pounds (35 kg).
Generic lenacapavir HIV prevention under PEPFAR
The approval was granted under the President’s Emergency Plan for AIDS Relief (PEPFAR) program. Dr. Reddy’s says it reflects the company’s capabilities in developing and manufacturing complex medicines. Unitaid, Wits RHI and CHAI supported the accelerated development and regulatory pathway. Under the existing agreement, injectable lenacapavir will be available at US$40 per person per year across 120 countries covered by Gilead’s voluntary licence. CHAI’s chief executive, Neil Buddy Shah, said that getting a generic approved “just 16 months after the originator” shows what is possible when access is prioritized from the start.
Lenacapavir is a first-in-class, long-acting HIV-1 capsid inhibitor, and the release notes that WHO also recommends twice-yearly lenacapavir in its guidelines for HIV prevention. The first supplies are expected to reach countries before the end of 2026, with broader availability across eligible countries in 2027.
Why it matters
The release calls the approval tentative and presents it as a regulatory basis for WHO prequalification and national regulatory approvals. It gives no dates for those steps, so the forward-dated commitments are first supplies by the end of 2026 and broader rollout in 2027.
Wits RHI’s Professor Saiqa Mullick adds that an affordable drug alone is not enough, and that countries need health systems that are ready, providers who are confident, and communities that are engaged as partners. For local supply, see how South Africa shortlists local firms to produce the lenacapavir HIV prevention shot.
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