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Gilead's Newly Approved HIV Prevention Drug Poised To Add Billions To Future Sales

In June, 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.

On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion under accelerated review recommending lenacapavir—the company's injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk.

Also Read: Gilead's Lenacapavir Plan Faces Global Hurdles As It Commits To No-Profit Access for 2 Million

The final European Commission (EC) decision is expected later this year. If approved, lenacapavir will ...