The European Commission approved a twice-yearly injection to prevent HIV across the European Union.
Gilead confirmed the decision follows a recommendation from the European Medicines Agency last month.
The drug, lenacapavir, will be marketed as Yeytuo in the EU, Norway, Iceland, and Liechtenstein.
Lenacapavir Demonstrates Revolutionary Effectiveness
Lenacapavir acts as pre-exposure prophylaxis (PrEP), stopping HIV from multiplying and spreading in the body.
It protects both adults and adolescents from infection.
Clinical trials showed complete effectiveness, earning recognition as a major medical breakthrough of 2024.
Yeytuo replaces daily pills as Europe’s first twice-yearly PrEP option.
HIV Cases Surge in Europe
New HIV diagnoses rose 11.8 per cent in 2023, reaching over 24,700 in the EU, Norway, Iceland, and Liechtenstein.
Dr. Dietmar Berger said the rapid approval demonstrates Yeytuo’s urgent impact on HIV prevention.
The US FDA approved lenacapavir, and WHO endorsed it as an additional preventive tool.
Gilead Expands Global Reach
Gilead seeks regulatory approval in Australia, Brazil, Canada, South Africa, and Switzerland, adding Argentina, Mexico, and Peru soon.
The company will supply generic versions in 120 lower-income countries with high HIV prevalence.
Availability may remain limited after US funding cuts to global health programs earlier this year.
Continuing Global HIV Burden
HIV affects approximately 40.8 million people worldwide.
AIDS-related illnesses killed around 630,000 people globally last year.
