The European Commission has granted marketing authorization for Gilead Sciences’ twice-yearly injection for preventing HIV infection. The drug will be sold in Europe under the brand name Yeytuo. Extensive trials conducted in 2024 proved nearly 100% efficiency at preventing HIV.
The drug, known scientifically as lenacapavir, had already been approved in June 2025 by regulators in the United States, where it is marketed as Yeztugo. The Commission’s approval now applies to use in the EUs 27 member states, as well as Norway, Iceland, and Liechtenstein. Before the drug can be made available to patients, Gilead Sciences will need to establish pricing and reimbursement terms with health systems in each country.
The European Commission has approved the drug for the so-called pre-exposure prophylaxis. It is intended to reduce the risk of sexually-acquired HIV in adults and adolescents at increased risk of contracting the deadly virus.
In combination with safer sex practices lenacapavir will substantially reduce the risk of sexually acquired human immunodeficiency virus type 1 (HIV-1) infection. — The European Medicines Agency
The European Medicines Agency (EMA) had recommended granting a marketing authorisation in the European Union for lenacapavir for pre-exposure prophylaxis in the end of July 2025. The Agency highlighted that “in combination with safer sex practices the drug will substantially reduce the risk of sexually acquired human immunodeficiency virus type 1 (HIV-1) infection”.
Extremely effective, yet at a price
Lenacapavir proved nearly 100% effective at preventing HIV in large trials last year. It raised new hope of interrupting transmission of the virus that infects some 1.3 million people a year. However, such a high effectivity comes at a price: in the United States, Gilead’s list price for Yeztugo is over $28,000 a year. Some US insurers are holding off on covering the new injection, citing its high price compared to generic pills.
Analysts project the drug will have sales of over $4bn a year by 2029.
You might be interested
Australia, Brazil, South Africa, and more
Gilead has submitted further applications for review by regulatory authorities in Australia, Brazil, Canada, South Africa, and Switzerland. It is also preparing applications in Argentina, Mexico, and Peru.
World Health Organization (WHO) has recommended that countries offer the drug as an additional prevention option for people at risk of contracting the virus.
Gilead plans, with the Global Fund to Fight AIDS, Tuberculosis and Malaria, to supply lenacapavir for up to two million people in low-income countries over three years. Generic drugmakers will gear up production under the royalty-free agreements.
Approximately 630,000 people worldwide died last year from AIDS, caused by the HIV virus. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates, over 40 million people are infected with the virus. The spread of HIV can be prevented by using condoms, taking special pills daily, or receiving a previously approved injection.
