Lenacapavir injectable PrEP approved in Europe – UK application later in 2025

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.

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]

In response, Gilead explained that the CHMP’s positive scientific opinion serves as the final step in the EU-M4All pathway, so that this has also been reach. The EU-M4all opinion will be included as a supporting reference when filing for national approvals.

The EU-M4All application for lenacapavir for PrEP (L4P) was evaluated using the same data submitted for the EU-MAA, including results from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. The difference in decision timelines stems from the distinct regulatory frameworks: while the EU-MAA requires a formal EC decision post-CHMP opinion, the EU-M4All process concludes with the CHMP opinion itself.

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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.

By the end of 2025, Gilead plans to have filed for PrEP approval in at least 15 countries, including: Botswana, Ethiopia, Kenya, Malawi, Mozambique, Namibia, Nigeria, Rwanda, Tanzania, Uganda, Zambia, Zimbabwe, Philippines, Thailand and Vietnam. Gilead has already submitted a regulatory filing in South Africa.

Lenacapavir for PrEP has not yet been submitted to the MHRA for approval in the UK. This should be done later this year under the International Recognition Procedure (IRP) which allows earlier decisions from other agencies, including the European Medicines Agency, to enable the MHRA to make a faster decision.

Note: This article was published on 26 August 2025 and updated on 19 September to include information about the EU-M4All and UK applications.