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FDA Approves Six-Month HIV Prevention Injection Lenacapavir

Now under Health Canada review, Gilead is exploring licensing deals to counter its US$28,000 annual cost; global roll-out hinges on affordable generic production.

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A pharmacist holds a vial of lenacapavir, the new HIV prevention injectable drug, at the Desmond Tutu Health Foundation's Masiphumelele Research Site, in Cape Town, South Africa, Tuesday, July 23, 2024.

Overview

  • The FDA authorized lenacapavir on June 24, 2025, for twice-yearly HIV pre-exposure prophylaxis injections.
  • Gilead submitted the drug to Health Canada in April 2025, with regulators aiming for a mid-2026 decision.
  • Clinical trials showed lenacapavir cut new HIV infections by more than 99% and caused only mild injection-site discomfort.
  • U.S. list pricing is about US$28,000 per year, driving negotiations with payers and plans to license generics for low- and middle-income countries.
  • Recipients must test negative for HIV before each dose, and lenacapavir does not protect against other sexually transmitted infections.