Gilead’s PrEP Yeztugo gains FDA green light

The US Food and Drug Administration (FDA) has approved Gilead Sciences (Nasdaq: GILD) Yeztugo (lenacapavir) - the company’s injectable HIV-1 capsid inhibitor - as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg.

According to Gilead, this makes the drug 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.

The global pre-exposure prophylaxis (PrEP) market size was valued at around $1.6 billion in 2023 and is projected to reach $5.3 billion by 2032, growing at a compound annual growth rate (CAGR) of around 14.5% during the forecast period.