Key Insights:
- European Commission authorizes Yeytuo as the first and only twice-yearly PrEP option, covering all 27 EU states plus Norway, Iceland, and Liechtenstein.
- Phase 3 PURPOSE trials showed 100% infection prevention in cisgender women and 99.9% prevention in men and gender-diverse participants.
- With global filings and a partnership with The Global Fund, Gilead aims to reach up to 2 million people in LMICs, accelerating progress toward ending HIV.
A Historic European Approval That Expands Prevention Choices
The European Commission granted marketing authorization for Gilead’s Yeytuo (lenacapavir), a twice-yearly injectable HIV-1 capsid inhibitor, marking a first-of-its-kind PrEP option in the region. The approval followed an accelerated review, reflecting its major public health impact. Coming just months after U.S. FDA approval, Yeytuo is now positioned to transform prevention strategies across Europe, where 25,000 new HIV cases are reported annually.
Groundbreaking Clinical Evidence Validates Long-Acting Protection
The authorization was supported by Phase 3 PURPOSE trials, delivering unprecedented results. In PURPOSE 1, involving 2,134 cisgender women in sub-Saharan Africa, zero HIV infections were observed, demonstrating clear superiority over daily oral Truvada. In PURPOSE 2, which included 2,179 cisgender men and gender-diverse participants worldwide, lenacapavir achieved a 99.9% protection rate, again proving superior to existing prevention regimens. Both studies confirmed strong tolerability, cementing Yeytuo as a breakthrough.
A Global Strategy to Broaden Access Beyond High-Income Regions
Gilead is executing an ambitious global rollout, with filings underway in Australia, Brazil, Canada, South Africa, and Switzerland, alongside plans for Latin America. Through the EU-M4all procedure, submissions in low- and middle-income countries will benefit from streamlined reviews, targeting 18 nations that carry 70% of the HIV burden. This strategy ensures faster, equitable access where the need is greatest.
Industry Partnerships Aim to Accelerate Ending the HIV Epidemic
To maximize reach, Gilead has partnered with The Global Fund to Fight AIDS, Tuberculosis and Malaria, planning to supply lenacapavir for PrEP to up to 2 million people in low- and lower-middle-income countries, pending approval. Combined with WHO’s updated guidance supporting twice-yearly dosing, this collaboration underlines Yeytuo’s role as a transformative tool in the fight against HIV.
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