Overview

• Lenacapavir, marketed as Yeztugo, received FDA approval on June 19 as the first HIV prevention injection administered twice annually.
• Clinical trials demonstrated near-100% efficacy, significantly outperforming daily oral PrEP options in at-risk populations.
• Gilead set a US list price of $28,218 per year and is working with insurers and assistance programs to support patient access.
• The company has agreements with six generic manufacturers to supply two million doses at no profit across 120 low-income countries.
• Health experts warn that recent cuts to HIV prevention funding and the high cost could limit uptake and leave vulnerable groups without protection.