Lenacapavir injectable PrEP approved in Europe

Simon Collins, HIV i-Base

On 26 August 2025, the European Medicines Agency (EMA) approved lenacapavir for use as PrEP. [1]

Lenacapavir is given as a sub-cutaneous injection every six months which overcomes the difficulties many people have taking oral PrEP, which helped produced extremely high levels of protection.

This follows FDA approval in June 2025. [2]

Lenacapavir is marketed by Gilead Sciences with the trade name Yeytuo in the EU and Yeztugo in the US.

Gilead has also submitted lenacapavir to regulatory agencies in Australia, Brazil, Canada and South Africa and is preparing filings in Argentina, Mexico and Peru.

However, the press statements did not refer to the current status of the EU-Medicines for all (EU-M4all) application to the EMA, which was submitted at the same time. This can be used by regulatory agencies outside the EU to accelerate access, including in low- and lower-middle-income countries. [3]

comment

Similar to our comment following US approval, lenacapavir is a remarkable breakthrough, with considerable promise to end new HIV transmissions.

Everything now depends on price and this is likely to prove a challenge for anyone hoping to access lenacapavir PrEP in the UK.

The challenge to Gilead is to set a launch price, including in the UK, which will enable rapid and widespread access to this incredible option.

References

Gilead press release. Yeytuo is the First and Only European Commission (EC)-Authorized HIV PrEP Option Offering 6 Months of Protection. (26 August 2025).
https://www.businesswire.com/news/home/20250825698635/en/European-Commission-Authorizes-Twice-Yearly-Yeytuo-Lenacapavir-for-HIV-Prevention

Long-acting injectable PrEP approved in the US: priced at $28,000 a year. HTB. 1 July 2025.
https://i-base.info/htb/51357

Lenacapavir for PrEP submitted to EMA for EU and global use. HTB (04 February 2025).
https://i-base.info/htb/50208