Lenacapavir on track for PrEP approval in Europe: questions on access
25 July 2025. Related: Early access, Antiretrovirals, HIV prevention and transmission.
Simon Collins, HIV i-Base
On 25 July 2025, the European Medicines Agency (EMA) issued a press release about the positive indication for lenacapavir to be approved as PrEP in the EU. [1]
Approvals based on such recommendations usually follow within 1 to 3 months.
In consideration of the new indication, the patent will be extended by a further year.
Lenacapavir was highly effective and safe in two large randomised international studies (PURPOSE 1 and PURPOSE 2), both previously reported in HTB.
Post-approval access though will be closely related to the price charged, which is currently listed as US$28,000 a year (2 x 6-monthly injections). This is likely to need a significant discount for it to be prescribed in Europe. [2]
Lenacapavir was developed by Gilead Sciences and is marketed for PrEP as Yeztugo in the US. The brand name for PrEP in the EU will be Yeytuo.
The brand name for the indication to treat MDR HIV is Sunlenca.
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The international phase 3 PURPOSE 1 and 2 studies showed that lenacapavir as PrEP is both remarkably effective and safe.
This is only relevant though if it can be widely used and this depends on pricing.
Setting aside the actual development costs for lenacapavir – because these are never explained by any company – the production costs, at scale, could be extremely low. For example, several research groups have reported that generic formulations could be produced for less than US$40 per year. [3]
Yet, based on the pricing and distribution strategy in the US, even with various access programme, no-one in the UK should expect to access this dynamic new way to protect against HIV. [4]
Although it is still hoped that NICE will shortly approve injectable cabotegravir-LA as PrEP, the organisation seems to have made the process difficult. Rather than looking for cost-effectiveness based on the likely limited use, NICE decided to ask for cost-effectiveness based on everyone who might use any PrEP.
Similarly, NHS England and Gilead have failed to agree a price for lenacapavir to become available as a life-saving treatment for people with multidrug resistance and limited treatment options. [5]
Issues related to lenacapavir have been carefully explained in detail in a recent opinion article in Lancet HIV. [6]
This rationale it included for broad and rapid access are also supported in a related editorial, heartbreakingly entitled ‘daring to dream’. [7]
References
- EMA. New injection for easier prevention of HIV infection in the EU and worldwide. (25 July 2025).
https://www.ema.europa.eu/en/news/new-injection-easier-prevention-hiv-infection-eu-worldwide - 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 could be produced for $40 a year: 1000-fold lower than current US price for treating MDR HIV. (26 July 2024).
https://i-base.info/htb/49073 - 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 EAP in the UK closed to new referrals: NHS England and Gilead fail to agree a price after more than two years. HTB. (1 April 2025).
https://i-base.info/htb/50940 -
Lynch S et al. Lessons for long-acting lenacapavir: catalysing equitable PrEP access in low-income and middle-income countries. Lancet HIV. Personal view. (11 July 2025).
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Daring to dream of long-acting HIV prevention. The Lancet HIV. (11 July 2025).