FDA Approves Generic Twice-Yearly HIV Prevention Shot for 120 Countries

The U.S. Food and Drug Administration has given tentative approval to a generic version of lenacapavir, the world's only twice-yearly HIV prevention shot, developed by India's Dr. Reddy's Laboratories. The approval raises hopes for a major expansion of HIV prevention in countries where the branded drug has been out of reach.

The generic is expected to cost $40 per person per year in 120 low- and middle-income countries, a fraction of the branded version's price. Lenacapavir is taken as an injection just twice a year, a schedule that researchers say could transform prevention for people who struggle with daily pills.

The generic cannot be sold as a generic in the United States while Gilead's branded version remains under patent. The FDA's tentative approval means the product meets U.S. safety and quality standards and can be distributed in the licensed countries.

HIV prevention advocates have long argued that price, not science, is the main barrier to wider use of long-acting prevention. A $40 annual cost would put the shot within reach of national health programs and global funders that have previously been priced out.

Rollout will still take time: manufacturers must scale production, and countries must add the shot to their prevention programs. But health officials said the approval marks one of the most significant steps yet toward making twice-yearly prevention a realistic option worldwide.