The European Commission approved a twice-yearly HIV prevention injection for rollout across the European Union.
Gilead confirmed the move follows a European Medicines Agency recommendation issued last month.
Lenacapavir, sold as Yeytuo, will also reach Norway, Iceland, and Liechtenstein.
New Drug Halts HIV Replication
Lenacapavir works as pre-exposure prophylaxis (PrEP), stopping HIV from multiplying and spreading in the body.
The injection protects both adolescents and adults from infection.
Clinical trials showed 100 percent effectiveness, earning praise as a major medical breakthrough of 2024.
Yeytuo offers the first twice-yearly PrEP option, replacing the need for daily pills.
Rising Cases Spur Fast Approval
HIV diagnoses rose 11.8 percent in 2023, totaling over 24,700 across the EU, Norway, Iceland, and Liechtenstein.
Dr. Dietmar Berger called the rapid approval “transformative” for European HIV prevention efforts.
The US FDA also approved the drug, while WHO recommends it as an additional prevention method.
Gilead Seeks Global Access
Gilead pursues approval in Australia, Brazil, Canada, South Africa, and Switzerland, with Argentina, Mexico, and Peru to follow.
The company will sell generic versions in 120 lower-income countries with high HIV rates.
Availability may remain limited after the US reduced global health funding earlier this year.
Global HIV Epidemic Remains Severe
HIV currently affects approximately 40.8 million people worldwide.
AIDS-related illnesses killed an estimated 630,000 people last year.
