US grants preliminary approval for low-cost version of HIV prevention drug

India's Dr. Reddy's Laboratories received preliminary approval from the US Food and Drug Administration for a generic version of the HIV prevention drug lenacapavir, priced at $40 per person annually in 120 low- and middle-income countries.

India's Dr. Reddy's Laboratories received preliminary approval from the US Food and Drug Administration for a generic version of lenacapavir, an HIV prevention drug administered via two injections per year. The initiative aims to provide the drug at $40 per person annually in 120 low- and middle-income countries. The company and the Unitaid health initiative announced the approval, with first supplies expected to reach some countries before the end of 2026, ahead of broader distribution in 2027. Carmen Perez Casas, Unitaid's strategy lead for HIV and pandemic preparedness, noted that moving from regulatory approval to actual distribution still requires further work. The approval does not allow marketing the generic version in the United States due to ongoing patent protection for the original drug developed by Gilead Sciences, but the US regulatory pathway enables quality assessment of drugs intended for international health programs, which may help accelerate their review and approval in other countries.