The European Commission authorized a twice-yearly injection to prevent HIV, drugmaker Gilead announced.
The ruling followed a European Medicines Agency recommendation one month earlier.
Regulators cleared lenacapavir, marketed as Yeytuo, for use across the EU, Norway, Iceland, and Liechtenstein.
Lenacapavir Shows Full Protection in Trials
Lenacapavir acts as pre-exposure prophylaxis, stopping HIV from replicating inside the body.
Clinical studies showed the jab prevented every infection, leading experts to hail it as a major breakthrough.
The drug protects adults and adolescents, replacing the need for daily preventive pills.
Experts Highlight Urgent Need
Gilead’s chief medical officer Dietmar Berger praised the Commission’s swift decision.
He emphasized Yeytuo’s potential to address urgent gaps in HIV prevention across Europe.
HIV cases rose 11.8 percent in 2023, reaching over 24,700 diagnoses in the EU and nearby countries.
Global Reach and Challenges
The US FDA also approved the injection, and the WHO endorsed it as an additional preventive option.
Gilead is seeking approval in Australia, Brazil, Canada, South Africa, and Switzerland, with more countries to follow.
The company will provide generic versions in 120 lower-income nations with high HIV burdens.
Uncertainty remains over access after the US cut global health funding earlier this year.
HIV Remains a Global Crisis
About 40.8 million people live with HIV worldwide.
An estimated 630,000 people died from AIDS-related illnesses last year.
Public health leaders stress that widespread access to Yeytuo could reshape the fight against HIV.
