FDA tentatively approves a $40-a-year generic HIV prevention shot

What happened, and the wording problem

The FDA has tentatively approved Dr. Reddy's Laboratories to make a generic version of lenacapavir, the twice-yearly injection for HIV prevention. The company plans to start shipping next month, and the annual cost is $40 per person, comparable to daily tablets, as first reported by STAT.

One caveat first. STAT's headline says the FDA "OKs" the shot, but the article text describes a tentative approval. Science's report says the FDA gave its seal of approval and calls Dr. Reddy's the first of six licensed generic makers to win it.

We could not retrieve the FDA's own notice or a company statement, so we are using the more cautious wording until we can. The brand-name drug, Gilead's Yeztugo, was approved by the FDA in 2025.

What the evidence for the drug says

The approval rests on trials of the brand-name drug, not new efficacy data on the generic. Both major trials were sponsor-funded, and both compared lenacapavir with estimated background HIV incidence as well as with daily oral PrEP.

PURPOSE 1, published in the NEJM, randomized participants 2:2:1 to lenacapavir, daily F/TAF or daily F/TDF. Background incidence in the screened group of 8,094 people was 2.41 per 100 person-years. Nobody on lenacapavir acquired HIV.

In PURPOSE 2, incidence was 0.10 per 100 person-years on lenacapavir versus 0.93 on F/TDF, per the CDC's clinical recommendation and a Lancet Global Health piece. WHO's systematic review puts efficacy against background incidence at 100% and 96% across the two trials.

Adverse-event rates were similar across arms. Discontinuation was very low and mostly tied to injection-site reactions. STI incidence was similar across arms in PURPOSE 1, but PURPOSE 2 saw more incident STIs on lenacapavir than on TDF/FTC.

What this does not show

• It is not a placebo-controlled result. The main comparison was against estimated background incidence, a modeled stand-in.
• It does not settle the regulatory status. We have not seen the FDA notice, so "tentative" versus full approval is unconfirmed.
• It does not cover everyone. A commentary in a PMC journal notes the trials do not cover all special groups, and we did not verify specifics for pregnant or breastfeeding people.
• It does not show real-world effectiveness. The notes we reviewed contain no post-trial data on adherence or outcomes.
• It does not yet put the drug on shelves. Science reports that individual countries must still approve the product.

What it means for you

If you live in the US, nothing we retrieved says this approval changes prices or access here. It is aimed at lower-income countries.

Your options are unchanged: the CDC issued a US recommendation for injectable lenacapavir as PrEP after the FDA's June 2025 approval, and daily oral PrEP remains an established choice. Which one fits depends on your testing schedule, how you feel about injections, and your clinician's advice.

What the news does signal is that a drug once confined to high-income markets may reach far more people. WHO recommended twice-yearly lenacapavir in July 2025 as an additional PrEP option within combination prevention, not a replacement for existing ones.

The access picture is better, not finished

Gilead's licenses let six generic makers sell only to 120 low- and lower-middle-income countries. In September 2025, Unitaid, the Clinton Health Access Initiative and Wits RHI backed Dr. Reddy's to supply the drug at $40 per patient per year, targeting availability from 2027. Shipping next month would be earlier than that.

Science says the price is comparable to what South Africa pays for a person's annual oral PrEP supply. South Africa has about 8 million people living with HIV.

Gaps remain. Andrew Hill of the University of Liverpool told The Lancet Microbe that about 30% of HIV transmission occurs in countries excluded from the license, including parts of South America, the Middle East, North Africa and Central Asia. The same piece notes some experts still consider $40 expensive given many national budgets.

A PMC commentary warns of supply constraints and the logistics of delivering twice-yearly injections. WHO counted 1.3 million new HIV infections in 2024 and urged countries to roll the drug out while collecting data on uptake, adherence and real-world impact.