FDA Accepts Gilead’s Application for Once-Weekly HIV Prevention Pill

Event summary

  • FDA accepted Gilead’s sNDA for Yeztugo (lenacapavir) as a once-weekly oral HIV prevention pill.
  • PDUFA action date set for February 2, 2027.
  • If approved, Yeztugo would be the first long-acting oral PrEP option.
  • Submission supported by PURPOSE 1 and PURPOSE 2 trial results.
  • Lenacapavir is already approved for twice-yearly injections and oral tablets as bridge therapy.

The big picture

Gilead’s filing for a once-weekly oral HIV prevention pill underscores its commitment to expanding HIV prevention options. The move aligns with broader industry trends toward long-acting therapies and personalized medicine, potentially broadening access to PrEP for diverse populations. If approved, Yeztugo could become a key player in the HIV prevention market, competing with existing daily oral PrEP options.

What we're watching

Approval Timeline
Whether the FDA will meet the February 2, 2027 PDUFA action date for Yeztugo’s once-weekly oral formulation.
Market Adoption
How the introduction of a once-weekly oral PrEP option will affect adoption rates among diverse global populations.
Competitive Dynamics
The pace at which Gilead can expand its HIV prevention portfolio with long-acting oral and injectable options.