The European Commission has formally approved lenacapavir, a revolutionary twice-yearly injection designed to prevent HIV, paving the way for its rollout across the European Union. Gilead Sciences will market the drug under the name Yeytuo.
The approval follows last month’s recommendation by the European Medicines Agency (EMA), which described the medicine as a game-changer in the battle against HIV.
It is the first pre-exposure prophylaxis (PrEP) option available as a twice-yearly injection, offering a major alternative to the current daily pill regimen.
Lenacapavir prevents HIV from replicating and spreading in the body, significantly lowering the risk of infection in both adults and adolescents.
In clinical studies, the injection showed 100 per cent effectiveness in preventing HIV transmission. Experts have hailed it as one of the most significant medical breakthroughs of 2024.
Dr Dietmar Berger, Gilead’s chief medical officer, said, “The Commission’s quick approval underscores the transformative potential of Yeytuo to help address the urgent unmet need in HIV prevention across Europe.”
Rising HIV Cases Across Europe
The rollout of lenacapavir comes amid a concerning rise in HIV infections. Health authorities reported over 24,700 new HIV diagnoses across the EU, Iceland, Liechtenstein, and Norway in 2023, marking an 11.8 per cent increase compared to 2022.
Yeytuo will be available in all EU member states, as well as in Norway, Iceland, and Liechtenstein.
The US Food and Drug Administration (FDA) has already approved the drug, and the World Health Organisation (WHO) has recommended it as an additional option for HIV prevention.
Gilead is now seeking approval in Australia, Brazil, Canada, South Africa, and Switzerland, with plans to include Argentina, Mexico, and Peru soon. The company has also committed to making generic versions available in 120 low-income countries with high HIV prevalence.
However, global health experts have raised concerns about access after recent US funding cuts, questioning how widely the drug can be distributed in high-need regions.
Globally, HIV continues to affect 40.8 million people, with an estimated 630,000 deaths from AIDS-related illnesses in the past year.
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