The European Commission has approved Gilead’s Yeytuo (lenacapavir) for HIV-1 prevention, opening a new chapter in the fight against the epidemic and strengthening its potential to become a blockbuster on the pharmaceutical market.
The new drug is approved as a pre-exposure prophylaxis (PrEP) option for adults and adolescents who are at increased risk of HIV-1 infection and weigh 35 kg or more. The drug works by blocking several stages of the virus’s life cycle, preventing it from multiplying. A unique feature of Yeytuo is that it is administered subcutaneously only twice a year, making it more convenient than traditional daily pill regimens.
The European Commission’s approval was the result of an accelerated regulatory review following a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in July. According to Gilead, this will also give the drug an additional year of market exclusivity.
The EU decision came shortly after a similar move by the FDA in the US, where the drug, under the brand name Yeztugo, was approved in June 2024. GlobalData analysts called the US approval a “historic step” in HIV prevention, and now this status extends to Europe, where approximately 24,700 new cases of infection were registered in 2023.
Organizations fighting HIV also praised the new drug. The Elton John AIDS Foundation called lenacapavir “a breakthrough prevention method that could dramatically change the dynamics of new infections.”
Clinical trial data confirmed the drug’s effectiveness. In the PURPOSE 1 study, there were no cases of infection, while in PURPOSE 2, the protection rate was 99.9%. In total, more than 4,300 volunteers participated in the trials.
Unlike most current PrEP therapies, which require daily pill intake and often have compliance issues, Yeytuo’s long-acting effect provides six months of protection after a single injection. As Jean-Michel Molina, professor of infectious diseases at Paris Cité University, points out, “the new twice-yearly regimen could be the solution Europe has been waiting for to really slow the HIV epidemic.”
The WHO has also expressed its support, recognizing injectable lenacapavir as an extremely effective drug and calling it “the best alternative to a vaccine,” which pharmaceutical companies have not yet developed.
The economic potential is also impressive. According to GlobalData forecasts, global sales of lenacapavir could reach $3.3 billion by 2031, and the drug will achieve “blockbuster” status as early as 2027. For comparison, Gilead’s current leader is the antiretroviral drug Biktarvy, with revenues of $13.4 billion in 2024.
However, cost remains a key challenge. In the US, Yeztugo costs $28,218 per year per patient, while another injectable PrEP, Apretude from GSK, costs $22,000 but is administered monthly. There is no information yet on reimbursement or pricing for Yeytuo in the EU.
Gilead is actively expanding its geography. The company has submitted applications for approval in Australia, Brazil, Canada, South Africa, and Switzerland, and plans to apply in Argentina, Mexico, and Peru. In addition, accelerated licensing is being prepared in low- and middle-income countries, including 18 countries that account for 70% of the global HIV burden.
To ensure access, Gilead has already partnered with the Global Fund to supply lenacapavir to two million people in low-income countries over three years.