Overview

• The FDA will issue its decision on lenacapavir’s approval for HIV prevention by June 19, 2025.
• Interim results from the Phase 3 PURPOSE 1 trial showed twice-yearly injections prevented HIV infection with 100 percent efficacy in cisgender women.
• Gilead has partnerships with six generic manufacturers to supply lenacapavir in 120 low-income countries and will deliver two million doses at no profit before generics launch.
• University of Liverpool analysis estimates that large-scale production could reduce annual costs to as low as $25 per patient, compared with anticipated US prices near $25,000.
• Advocacy groups have raised concerns over the exclusion of Brazil, Argentina and parts of Eastern Europe from Gilead’s licensing agreements.