FDA grants tentative approval to Dr Reddy's generic lenacapavir

Tentative approval for Dr Reddy's generic

The FDA granted tentative approval to Dr Reddy's Laboratories' generic lenacapavir on 2 November. The Indian manufacturer developed it with financial, technical and regulatory support from Unitaid, Wits RHI and the Clinton Health Access Initiative. Unitaid said the decision came just 16 months after the originator product was approved, one of the fastest timelines to approval for a major HIV innovation to date.

Tentative is the operative word. Gilead's branded version, Yeztugo, remains patent-protected. The FDA uses the tentative designation for generics while the originator is under patent. It is a longstanding mechanism designed to ensure the quality of HIV-related medicines supplied to other countries through US government programmes, and it can speed regulatory clearances elsewhere.

Gilead granted royalty-free licences to six generic manufacturers in 2024. Dr Reddy's is the only licensee to have received tentative FDA approval so far.

Forty dollars against a $28,218 US list price

The $40 price was set in a September 2025 agreement between Unitaid, Wits RHI, the Clinton Health Access Initiative and Dr Reddy's. It is the same price as daily preventive pills available now, a comparison health ministries will make.

In the US, Yeztugo lists at $28,218 a year before insurance. The generic cannot be sold there while the patent holds.

Why a twice-yearly shot matters

Lenacapavir is given as one injection every six months. In the PURPOSE 1 trial among young women in South Africa and Uganda, no HIV infections occurred in the lenacapavir group against 16 in the daily Truvada arm. PURPOSE 2, which enrolled men and gender-diverse participants, recorded two infections among more than 2,000 people, a 96% reduction against the expected rate.

The need is large. WHO counted 41 million people living with HIV and 570,000 HIV-related deaths last year, with about 1.2 million new infections. The Clinton Health Access Initiative puts the number who need PrEP at 20 million worldwide.

Daily pills protect only while people keep taking them. That is the gap the injection fills. But each injection requires a prior HIV test, and drug-resistant HIV has been identified when the shot was given to people with an undiagnosed infection. Saiqa Mullick, director of implementation science at Wits RHI, said rapid tests are commonly used in low- and middle-income countries.

Rollout and the funding gap

Unitaid said first supplies are expected to reach countries before the end of the year, with broader availability in 2027. The agency said more than 125,000 people in 10 early adopter African countries have already started Gilead's lenacapavir. Demand in low- and middle-income countries has outstripped supply, according to the Associated Press.

Carmen Pérez Casas of Unitaid said people in lower- and middle-income countries had waited "a decade or more" for medicines already available elsewhere. The gap is now little more than a year, she said.

Rachel Vreeman, dean for global health at the Icahn School of Medicine at Mount Sinai, told CIDRAP the next critical step is large orders. She named the US government and the Global Fund as the buyers who matter. "Even a cheap drug needs someone to pay for it, and for staff and systems to deliver it," she said.

Country-by-country approvals will set the pace after that.