US Health Regulator Approves $40 Generic HIV Prevention Shot
The United States Food and Drug Administration (FDA) has granted tentative approval to a low-cost generic version of a twice-yearly HIV prevention injection, potentially expanding access to the drug across 120 low- and middle-income countries.
Indian pharmaceutical company Dr. Reddy’s Laboratories announced the approval on Monday, November 2, 2026, alongside global health initiative Unitaid. The approval was granted under the FDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) programme.
The generic medicine, lenacapavir, is expected to cost approximately $40 per person annually under an agreement involving Dr. Reddy’s, Unitaid, the Clinton Health Access Initiative and the Wits Reproductive Health and HIV Institute.
Originally developed by US pharmaceutical company Gilead Sciences, lenacapavir is administered twice a year for pre-exposure prophylaxis (PrEP), helping prevent HIV infection. Clinical trials have demonstrated very high effectiveness, offering an alternative to daily preventive pills.
The generic version was developed with financial, technical and regulatory support from the partner organisations to accelerate affordable access to the treatment. Initial supplies are expected to reach countries before the end of 2026, with wider availability anticipated in 2027.
However, the FDA’s tentative approval does not mean the injection will immediately be available everywhere. Access will depend on supply arrangements and the necessary regulatory approvals in individual countries.
The development is considered a significant milestone in global HIV prevention, particularly in regions such as sub-Saharan Africa, where the burden of HIV remains high and the cost and frequency of preventive medication can limit access.
