The European Commission authorized a twice-yearly injection to prevent HIV across the European Union.
Gilead confirmed the approval follows a European Medicines Agency recommendation last month.
The drug, lenacapavir, will be sold as Yeytuo in the EU, Norway, Iceland, and Liechtenstein.
Lenacapavir Offers Groundbreaking Protection
Lenacapavir works as pre-exposure prophylaxis (PrEP), stopping HIV from replicating and spreading in the body.
The injection protects both adults and adolescents from acquiring HIV.
Clinical trials showed 100 per cent effectiveness, prompting experts to call it a major 2024 breakthrough.
Yeytuo replaces daily pills as the first twice-yearly PrEP option in Europe.
Rising HIV Cases Drive Urgency
HIV diagnoses in 2023 rose 11.8 per cent to over 24,700 across the EU, Norway, Iceland, and Liechtenstein.
Dr. Dietmar Berger said the fast approval highlights Yeytuo’s transformative potential for HIV prevention.
The US FDA also approved lenacapavir, and WHO recommended it as an additional prevention method.
Global Expansion Plans
Gilead seeks approval in Australia, Brazil, Canada, South Africa, and Switzerland, adding Argentina, Mexico, and Peru soon.
The company agreed to sell generic versions in 120 lower-income countries with high HIV prevalence.
Experts caution availability may remain limited after US funding cuts to global health programs earlier this year.
Ongoing Global HIV Challenge
HIV currently affects about 40.8 million people worldwide.
Last year, AIDS-related illnesses caused an estimated 630,000 deaths globally.
