FDA Approves Gilead's Yeztugo As First Twice-Yearly Injectable PrEP For HIV Prevention

(RTTNews) - Gilead Sciences Inc. (GILD) announced that the U.S. Food and Drug Administration has approved Yeztugo (lenacapavir)-the company's injectable HIV-1 capsid inhibitor-as pre-exposure prophylaxis or PrEP to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP. Data show that 99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative.

Yeztugo (lenacapavir) is now the first and only HIV prevention option approved by the U.S. FDA that offers protection for six months.

Yeztugo received FDA approval under Priority Review. Additionally, in October 2024, Yeztugo was granted Breakthrough Therapy Designation, which is intended to expedite the development and review of new drugs that may demonstrate substantial improvement over available therapy.

Gilead noted that its U.S. access strategy for Yeztugo is designed to enable broad uptake and availability for individuals with and without insurance coverage. Additional regulatory filings are underway in countries around the world.

Lenacapavir for HIV prevention is not approved by any regulatory authority outside of the United States. There is currently no cure for HIV or AIDS.