The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has officially granted marketing authorization for lenacapavir (branded as Yeytuo) for pre-exposure prophylaxis (PrEP). This marks a significant shift from daily oral regimens to a twice-yearly injection schedule, available for both adults and adolescents at increased risk of infection.
Developed by Gilead Sciences, the drug works by interfering with the viral lifecycle, effectively preventing the virus from multiplying upon exposure. Clinical data indicates that this therapy offers near-total protection, outperforming traditional daily methods. By requiring only two clinical visits per year, the treatment minimizes the psychological burden on users and eliminates the risk of missed doses—a primary factor in previous PrEP failures.
The UK’s approval follows similar regulatory milestones in the United States and the European Union earlier in 2025. Currently, health advisory bodies are evaluating the drug for inclusion in the National Health Service (NHS) reimbursement framework. Simultaneously, the manufacturer has finalized agreements to provide generic versions in 120 low- and middle-income countries, ensuring equitable access in high-burden regions worldwide.
Source: https://www.pharmaceutical-technology.com/news/uk-approves-gileads-twice-yearly-hiv-prep-drug/?cf-view