The European Commission (EC) has granted marketing authorization to Gilead Sciences for Yeytuo (lenacapavir), making it the first and only twice-yearly injectable HIV pre-exposure prophylaxis (PrEP) option approved in the European Union, as well as in Norway, Iceland, and Liechtenstein.
Yeytuo is indicated for adults and adolescents at increased risk of sexually acquired HIV-1 who weigh at least 35kg. The drug’s approval follows a fast-tracked review by the European Medicines Agency (EMA) due to its potential significant public health impact.
“Yeytuo’s rapid authorization reflects the strength of our clinical data and the urgent need for new HIV prevention tools,” said Dr. Dietmar Berger, Gilead’s Chief Medical Officer.
The decision follows U.S. FDA approval in June and aligns with World Health Organization (WHO) guidance issued in July recommending twice-yearly lenacapavir as a new PrEP option.
Strong Phase 3 Trial Results
The EC approval is supported by two Phase 3 trials, PURPOSE 1 and PURPOSE 2. In PURPOSE 1, conducted in cisgender women in sub-Saharan Africa, no HIV infections occurred among 2,134 participants receiving lenacapavir—representing a 100% risk reduction compared to daily oral Truvada. PURPOSE 2, which included cisgender men and gender-diverse people across multiple regions, saw only two infections among 2,179 participants, demonstrating 99.9% effectiveness and superiority over oral PrEP.
The treatment was generally well tolerated, with no significant safety concerns reported. Results from both studies were published in The New England Journal of Medicine, and Science named lenacapavir its 2024 “Breakthrough of the Year.”
Expanding Global Access
Gilead is pursuing additional approvals in Australia, Brazil, Canada, South Africa, and Switzerland, and plans to file in Argentina, Mexico, and Peru. The company also intends to leverage the EU-M4all procedure to accelerate regulatory reviews in low- and middle-income countries, targeting 18 countries that represent 70% of the HIV burden across 120 nations included in Gilead’s voluntary licensing agreements.
In partnership with The Global Fund, Gilead aims to supply lenacapavir for PrEP to up to 2 million people in low- and lower-middle-income countries, pending further approvals.
“Yeytuo offers a transformational HIV prevention option,” said Dr. Jean-Michel Molina, infectious diseases specialist at Université Paris Cité. “Its long-acting formulation may help reduce new infections among Europe’s most vulnerable populations.”
There is currently no cure for HIV or AIDS, but long-acting PrEP options like Yeytuo represent a major advance in global prevention efforts.