UK Approves New HIV Prevention Drug Lenacapavir
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for lenacapavir, marketed as Yeytuo, to prevent sexually transmitted HIV-1 infections in adults and adolescents. The decision was made on 19 December 2025, marking a significant advancement in HIV prevention strategies.
How Lenacapavir Works
Lenacapavir functions by diminishing the likelihood of HIV-1 replication and spread within the body upon exposure to the virus. The drug binds to the outer structure of the virus, effectively disrupting its ability to multiply. Health professionals recommend using lenacapavir in conjunction with safer sex practices, such as condom use, to enhance its effectiveness.
Administration of Lenacapavir
This new medication is administered through a regimen that combines tablets and injections. Initially, patients will take tablets for two days, followed by an injection every six months. This long-acting option allows for better adherence and convenience in HIV prevention.
MHRA’s Commitment to Safety Monitoring
Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, commented on the significance of this breakthrough, stating that lenacapavir offers an important new preventative option alongside existing safe sex practices. He assured that the agency will continue to monitor the drug’s safety and effectiveness as it becomes more widely available.
The MHRA has also indicated that comprehensive side effect information will be made available via the Patient Information Leaflet and the Summary of Product Characteristics on their website within seven days of the approval. Those experiencing possible side effects are encouraged to consult with their healthcare provider.
Reporting Adverse Reactions
Lenacapavir will be subject to additional monitoring, allowing for the swift identification of new safety data. Healthcare professionals and patients are urged to report any adverse reactions through the MHRA’s Yellow Card scheme, which can be accessed online or via app stores.
Significance of the Approval
The approval of lenacapavir is a timely development in the global fight against HIV. With a focus on prevention, this new medication could play a crucial role in reducing transmission rates and improving public health outcomes. It aligns with efforts to enhance access to innovative treatments and support safe practices in sexual health across the UK.
Notes to Editors
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The MHRA granted approval for lenacapavir on 19 December 2025 to Gilead Sciences Ltd.
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Further details will be available in the Summary of Product Characteristics and Patient Information Leaflets on the MHRA website shortly.
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The MHRA is the regulatory body for medicines and medical devices in the UK and operates as an executive agency of the Department of Health and Social Care.
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For media inquiries, contact newscentre@mhra.gov.uk or call 020 3080 7651.
Source: official statements, news agencies, and public reports.
https://www.gov.uk/government/news/mhra-approves-lenacapavir-for-the-prevention-of-sexually-transmitted-hiv-1-infection
