The European Commission (EC) has approved Gilead’s Yeytuo (lenacapavir) for the prevention of HIV infection, consolidating the injectable drug’s potential to become one of the company’s leading products in the future.
Yeytuo is approved as a pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased risk of acquiring HIV-1 who weigh at least 35kg. The drug works by interfering with multiple steps in the viral lifecycle, thereby inhibiting HIV-1 replication. Yeytuo is administered as a subcutaneous injection twice yearly.
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The EC’s approval follows a positive recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last month. According to its accelerated regulatory pathway, Gilead said that Yeytuo will have an additional year of market protection.
The European marketing authorisation comes shortly after a similar decision in the US, where the US Food and Drug Administration (FDA) approved the injection – marketed under the brand name Yeztugo – in June 2024.
Yeztugo’s US approval was hailed as a ‘momentous step’ for HIV prevention by analysts at GlobalData. That same can also be applied to Yeytuo’s approval in Europe, a region that had around 24,700 new HIV diagnoses in 2023.
Similarly, the Elton John AIDS Foundation called the drug a “breakthrough prevention method that will fundamentally bend the curve of new HIV infections”.
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By GlobalDataClinical trials with twice-yearly subcutaneous lenacapavir demonstrated significantly high efficacy in stopping HIV infection. The PURPOSE 1 (NCT04994509) trial had a 100% success rate in preventing HIV infection while the drug prevented infections in 99.9% of participants in the PURPOSE 2 (NCT04925752) trial. The two studies collectively enrolled 4,313 participants.
Currently, most PrEP therapies require daily oral administration, which often leads to poor adherence. Lenacapavir, a long-acting antiretroviral agent that provides protection against HIV infection for six months and only needs to be administered twice a year, is more convenient.
“Yeytuo’s novel twice-yearly dosing schedule and high efficacy could be the transformative HIV prevention option in Europe we’ve been waiting for to help us reduce new infections and make real progress toward ending the HIV epidemic,” said Jean-Michel Molina, professor of infectious diseases at Université Paris Cité.
The World Health Organization (WHO) endorsed the use of injectable lenacapavir in the fight against HIV earlier this year, citing the drug’s high efficacy and long-acting nature. WHO director general Dr Tedros Adhanom Ghebreyesus said the shot was the “next best thing” after a vaccine, the latter remaining elusive in pharma so far.
GlobalData’s Pharma Intelligence Centre forecasts global sales of lenacapavir to reach $3.3bn by 2031, with the drug entering blockbuster status by 2027. Gilead’s top-selling drug is currently HIV antiviral Biktarvy, which generated global sales of $13.4bn in 2024.
However, a potential barrier to its global uptake could be cost, with the US list price for Yeztugo sitting at $28,218 per year for each patient. For comparison, GSK’s Apretude – the only other injectable PrEP therapy available in the US – costs $22,000 per year, though this is given monthly. Gilead has not disclosed any discussions relating to reimbursement and drug pricing in member states of the European Union.
Gilead has also filed for regulatory review of twice-yearly lenacapavir for PrEP with authorities in Australia, Brazil, Canada, South Africa and Switzerland. Further plans include Argentina, Mexico, and Peru.
The company said it also intends to pursue accelerated reviews in regulatory authorities in low- and middle-income countries. This includes priority registrations covering 18 countries that represent 70% of the HIV burden of the 120 countries named in Gilead’s voluntary licensing agreements.
Gilead has already entered a partnership 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.
