The European Commission approved a twice-yearly injection to prevent HIV across member states.
Gilead confirmed the authorization followed the European Medicines Agency’s recommendation last month.
Lenacapavir will be marketed as Yeytuo in the EU, Norway, Iceland, and Liechtenstein.
Lenacapavir Provides Strong Protection
Lenacapavir acts as pre-exposure prophylaxis (PrEP), stopping HIV from multiplying and spreading in the body.
The injection protects adults and adolescents from acquiring HIV.
Clinical trials showed 100% effectiveness, earning praise as a major medical breakthrough in 2024.
Yeytuo eliminates the need for daily PrEP pills as the first twice-yearly option in Europe.
Surge in HIV Cases Prompts Action
HIV diagnoses rose 11.8% in 2023 to over 24,700 in the EU, Norway, Iceland, and Liechtenstein.
Dr. Dietmar Berger said rapid approval highlights Yeytuo’s urgent role in European HIV prevention.
The US FDA approved lenacapavir, and WHO recommended it as an additional prevention tool.
Gilead Expands Global Access
Gilead seeks approvals in Australia, Brazil, Canada, South Africa, and Switzerland, adding Argentina, Mexico, and Peru soon.
The company will sell generics in 120 lower-income countries with high HIV prevalence.
Experts note availability may be limited after US cuts to global health funding earlier this year.
HIV Remains a Global Threat
HIV affects roughly 40.8 million people worldwide.
Last year, AIDS-related illnesses killed an estimated 630,000 people globally.