The European Commission approved lenacapavir, a twice-yearly HIV prevention injection developed by Gilead Sciences.
The decision followed the European Medicines Agency’s recommendation of the groundbreaking drug in July.
The jab will soon roll out across the EU, Norway, Iceland, and Liechtenstein under the name Yeytuo.
A Game-Changer in HIV Prevention
Lenacapavir, a pre-exposure prophylaxis (PrEP), blocks HIV from replicating and spreading in the body.
The treatment reduces infection risk in both adults and adolescents.
Clinical trials showed the injection was 100 percent effective, prompting experts to call it a major breakthrough in 2024.
Yeytuo will replace daily pills, offering the first twice-yearly PrEP option in Europe.
Gilead’s chief medical officer Dietmar Berger said the fast approval highlights the treatment’s transformative potential.
Global Expansion and Rising HIV Cases
The FDA and WHO have already endorsed lenacapavir as a new prevention option.
Gilead is pursuing approvals in Australia, Brazil, Canada, South Africa, Switzerland, and later in Argentina, Mexico, and Peru.
The company also agreed to license generic versions in 120 low-income countries with high HIV burdens.
In 2023, HIV diagnoses in the EU and nearby states rose to 24,700, an increase of 11.8 percent from 2022.
Worldwide, 40.8 million people live with HIV, and 630,000 died from AIDS-related illnesses last year.
