Gilead Sciences’ pre-exposure prophylaxis (PrEP) formula of lenacapavir has been approved in the UK as a preventative option for HIV, offering patients a twice-yearly injection to reduce the risk of contracting the virus.
As per the authorisation by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), lenacapavir will be available to adults and adolescents for the prevention of sexually transmitted HIV-1 infection.
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The drug, taken as an injection once every six months, will be sold in the UK under the brand name Yeytuo, as it is across Europe.
A formulation of lenacapavir was already approved in the UK under the brand name Sunlenca in 2022, which is for the treatment of HIV infection in combination with other antiretrovirals.
There were 6,402 new diagnoses of HIV in the UK in 2023, with 107,949 people receiving HIV care that year. The UK Government aims to stop new HIV transmissions and end AIDS-related deaths by 2030.
The greenlight as a preventative option in the UK follows similar decisions in the US and Europe earlier this year. In June, the US Food and Drug Administration (FDA) approved the twice-yearly treatment under the brand name Yeztugo, while the European Commission (EC) approved Yeytuo in August.
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By GlobalDataYeytuo works by reducing the risk of the HIV-1 virus multiplying and spreading throughout the body if a person is exposed to the virus. The drug binds to the HIV-1 virus’s outer layer, interfering with multiple steps in the viral lifecycle. The MHRA recommends Yeytuo’s use alongside safer sex practices, such as condoms.
Julian Beach, interim executive director of healthcare quality and access at the MHRA, stated: “The approval of Yeytuo marks the introduction of a six-monthly long-acting preventative option for sexually transmitted HIV-1 infection.
“Blocking the virus from multiplying if exposure occurs, lenacapavir offers an additional choice alongside existing safer sex practices.”
It is unclear whether the National Health Service (NHS) will offer the drug as a preventative option to patients. As per a National Institute for Health and Care Excellence (NICE) entry, a provisional committee meeting is scheduled for March 2026. NICE did not immediately respond to Pharmaceutical Technology when approached for comment on the progress of UK reimbursement for the drug.
Dr Paul Martin, chief executive of LGBT Foundation, a UK charity, said: “This approval [in the UK] is a game-changer for HIV prevention. Yeytuo gives people more choice, more control, and more hope. But we know progress cannot happen in isolation – ending new HIV transmissions by 2030 will take national collaboration, shared resources, and sustained investment.”
Yeytuo’s approvals this year have been hailed as a momentous step for HIV prevention. Currently, most PrEP therapies require daily oral administration, which often leads to poor adherence.
However, the drug’s cost has been a source of concern for accessibility. The US list price for Yeztugo is $28,218 per year for each patient. Gilead has allowed generics of the drug to be manufactured in 120 low- and middle-income countries to ensure that accessibility in areas of high risk is not a challenge, should the drug be approved in these countries.
The World Health Organization (WHO) endorsed the use of the PrEP treatment in the fight against HIV earlier this year, citing the drug’s high efficacy, long-acting nature, and improved convenience. 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.
The UK approval came alongside Gilead, in addition to eight other pharma companies, reaching a drug pricing deal with the Trump administration. Gilead will reduce the price of its Hepatitis C medication, Epclusa (sofosbuvir/velpatasvir), from $24,920 to $2,425 for patients purchasing directly through TrumpRx. In September, the drugmaker already agreed to deliver Yeztugo for up to two million people in the US as part of a partnership with the US State Department and the US President’s Emergency Plan for AIDS Relief (PEPFAR).
GlobalData forecasts that lenacapavir, under all its brand names, will generate $5.3bn in global sales in 2031.
GlobalData is the parent company of Pharmaceutical Technology.
