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FDA Approves Gilead's 'Game Changing' Twice-Yearly Shot To Prevent HIV Transmission, Critics Slam $28K Price Tag

During market trading hours on Wednesday, the U.S. Food and Drug Administration (FDA) approved Gilead Sciences, Inc.’s (NASDAQ:GILD) Yeztugo (lenacapavir) as pre-exposure prophylaxis (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 U.S. 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.

The first PrEP medication, which was also developed by Gilead, was approved in the U.S. in 2012.

Also Read: Gilead’s HIV Prevention Drug Could Be Manufactured At Shocking Low Cost: Report

In the PURPOSE 1 trial, data at the primary analysis showed twice-yearly subcutaneous Yeztugo demonstrated zero HIV infections among 2,134 participants in the Yeztugo group, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in cisgender women in sub-Saharan Africa.

In the PURPOSE 2 trial, there were two HIV infections among 2,179 participants in the twice-yearly ...