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FDA Approves Yeztugo, Twice-Yearly HIV Prevention Injection

High pricing paired with uncertain backing by major HIV funders threatens access in low-income nations

Overview

  • Lenacapavir, marketed as Yeztugo by Gilead Sciences, proved 99.9% effective in clinical trials with just two subcutaneous injections per year.
  • Gilead set a U.S. list price of $28,218 annually, far above the $25 per-person production estimate by independent researchers.
  • The company licensed six generic manufacturers to supply low-cost versions in 120 low-income countries and will provide 2 million doses at no profit until generics launch.
  • Recent cuts to funding programs including PEPFAR and the Global Fund have cast doubt on financing for widespread distribution in resource-limited regions.
  • Health experts and UNAIDS warn that without affordable pricing and reliable funding, the injection’s global impact on ending HIV transmission could be undermined.