European Commission approves HIV prevention injection
Ella Day | August 28, 2025 | News story | Medical Communications, Research and Development | European Commission, Gilead Science, HIV, HIV/AIDS, US Food and Drug Administration, World Health Organisation
The European Commission (EC) has granted marketing authorisation for Gilead Science’s Yeytuo (lenacapavir), the first twice-yearly injectable medicine approved in the European Union (EU) for pre-exposure prophylaxis (PrEP) against HIV.
The approval allows Yeytuo to be used in patients weighing at least 35kg who are at increased risk of acquiring HIV-1 through sex. Unlike existing daily oral PrEP medicines, Yeytuo is given as a single injection every six months.
The decision followed an accelerated review by the European Medicines Agency. It comes two months after approval by the US Food and Drug Administration and shortly after new World Health Organization guidelines recommended lenacapavir as an additional prevention option.
Yeytuo’s approval was supported by data from two phase 3 trials conducted by Gilead. In the PURPOSE 1 study, no HIV infections occurred among more than 2,000 cisgender women in sub-Saharan Africa who received the injection. In PURPOSE 2, involving cisgender men and gender-diverse people globally, the injection prevented almost all new infections and was found to be superior to daily oral PrEP.
Dietmar Berger, chief medical officer at Gilead Sciences, said: “Yeytuo’s rapid authorisation by the EC underscores the transformative potential of Yeytuo to help address the urgent unmet need in HIV prevention across Europe.”
According to the European Centre for Disease Prevention and Control, around 25,000 people are newly diagnosed with HIV each year in the EU and European Economic Area.
Ella Day
28/8/25
Related Content
FDA approves Wegovy for treatment of MASH in adults with liver fibrosis
The US Food and Drug Administration (FDA) has granted accelerated approval for Wegovy (semaglutide) as …
Global study calls for overhaul of hepatitis B care to meet WHO targets
A major global study has warned that current models of hepatitis B care are failing …
FDA decision on Neurizon’s ALS therapy delayed until October
Neurizon Therapeutics has announced that the US Food and Drug Administration (FDA) will delay its …
