FDA Tentatively Approves Generic HIV Prevention Shot at $40 a Year for Dozens of Low- and Middle-Income Countries
Written by AI from statnews.com's report. Not checked by a person.
The US FDA has given tentative approval to Dr. Reddy's Laboratories for a generic version of lenacapavir, a six-monthly injectable that provides near-complete HIV protection, priced at $40 per person per year — a key step toward wider access in dozens of low- and middle-income countries.
The US Food and Drug Administration has granted tentative approval to Dr. Reddy's Laboratories, one of the world's largest generic drugmakers, to manufacture a generic version of lenacapavir — a groundbreaking injectable medicine for HIV prevention. The decision, announced on November 2, 2026, is considered a major step toward making the drug accessible in dozens of low- and middle-income countries.
Lenacapavir works by offering virtually complete protection against HIV infection with just a single injection every six months, setting it apart from daily oral pills that require consistent daily adherence. The annual cost for the generic version will be $40 per person, comparable to the cost of daily tablet regimens.
Dr. Reddy's plans to begin shipping the medicine as early as next month, an effort supported in part by several global health organizations pushing for rapid availability in lower-income nations.
The brand-name version of the drug, known as Yetzugo in the United States, is made by Gilead Sciences and received FDA approval last year. The tentative approval of a generic so soon after the originator's clearance reflects the urgency felt by the global health community in addressing HIV in lower-income settings.
Health advocates have long viewed lenacapavir as a potentially transformative tool in the effort to end the HIV epidemic, particularly given how the six-monthly injection could make prevention far more practical for people in regions where daily pill regimens are harder to maintain.
