European regulators have greenlit a twice-yearly injection to prevent HIV that has been hailed as a game-changer in the course of the epidemic.
The jab from the drugmaker Gilead was considered one of the biggest medical breakthroughs of 2024, offering an alternative to daily pills. The drug, called lenacapavir, was 100 per cent effective at preventing the virus in clinical studies.
It is a form of pre-exposure prophylaxis (PrEP), which works by preventing the virus from replicating and spreading within the body. It reduces the risk of acquiring HIV among both adults and adolescents.
The European Medicines Agency’s (EMA) advisory committee issued a positive opinion of the drug on Friday, clearing the way for the European Commission to approve the drug in the coming months.
“This milestone reflects our commitment to reimagine HIV prevention in Europe and around the world,” Dr Dietmar Berger, Gilead Sciences’ chief medical officer, said in a statement.
“Lenacapavir for PrEP has the potential to become a critical tool for public health, helping to expand prevention options for people who face the highest barriers to care”.
While there has been progress in the fight against HIV, cases have been rising. In 2023, there were more than 24,700 new HIV diagnoses in the European Union, Iceland, Liechtenstein, and Norway, up 11.8 per cent from 2022.
"PrEP is a cornerstone of HIV-control efforts in Europe and worldwide and is very effective at preventing infections if taken as prescribed," the EMA said in a statement.
"However, uptake and adherence are often suboptimal because access to some medicines is limited, and other available medicines require strict daily intake".
That's why health experts believe that having a twice-yearly injection available could boost efforts to control HIV, which affects about 40.8 million people worldwide. An estimated 630,000 people died from AIDS-related illnesses last year.
The US Food and Drug Administration (FDA) also approved the new drug last month. In the EU, Gilead expects to sell it under the name Yeytuo.
Gilead has agreed to sell generic versions of the drug in 120 lower-income countries with high HIV rates. But it is not yet clear how widely available it will be after the United States, which has traditionally been a major global health donor, slashed funding earlier this year.
Updated July 25: This story has been updated with a comment from the European Medicines Agency.
