EU clears twice-yearly HIV shot lenacapavir, paving way for Europe rollout

The European Commission has formally approved a twice-yearly injection to prevent HIV, paving the way for its rollout across the European Union, Euro News reported, citing drugmaker Gilead.

The new treatment comes amid a rise in HIV cases across parts of Europe.

The approval follows a recommendation last month from the European Medicines Agency (EMA) for the first-of-its-kind medicine, which has been hailed as a game-changer in the fight against the HIV epidemic, Euro News added.

The drug, called lenacapavir, is a form of pre-exposure prophylaxis (PrEP) that prevents the virus from replicating and spreading within the body, reducing the risk of acquiring HIV among both adults and adolescents.

In clinical studies, the jab was 100 per cent effective at preventing the virus, prompting experts to call it one of the biggest medical breakthroughs of 2024, Euro News reported.

Lenacapavir will be sold as Yeytuo in the European Union, Norway, Iceland, and Liechtenstein. It will be the first twice-yearly PrEP option available, replacing the need for daily pills.

Dr Dietmar Berger, Gilead Sciences' 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."

The new treatment comes as HIV cases rise. In 2023, more than 24,700 new HIV diagnoses were reported in the EU, Iceland, Liechtenstein, and Norway, marking an 11.8 per cent increase from 2022.

The US Food and Drug Administration (FDA) has also approved the drug, and the World Health Organization (WHO) has recommended it as an additional option to prevent HIV.

Gilead said it is seeking approval for lenacapavir in Australia, Brazil, Canada, South Africa, and Switzerland, and will soon add Argentina, Mexico, and Peru to the list. The company has also agreed to sell generic versions of the drug in 120 lower-income countries with high HIV rates. However, availability remains uncertain following US funding cuts earlier this year, Euro News reported.

Globally, HIV affects about 40.8 million people, with an estimated 630,000 deaths from AIDS-related illnesses reported last year.