New Injectable Recommended by Europe for HIV Prevention

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization in the European Union (EU) for a twice-yearly injection to prevent HIV, in combination with safer sex practices. 

The EMA said Yeytuo (lenacapavir) was evaluated by the CHMP under an accelerated timeline due to its major public health interest in the EU and beyond.

Yeytuo is anticipated to facilitate preexposure prophylaxis (PrEP) uptake and compliance as it only has to be administered twice a year, allowing patients to overcome several barriers associated with the daily oral pill for PrEP and other shorter-acting options. It also was recently approved by the US FDA. 

Thanks to advances in prevention and treatment, global HIV infection rates have been drastically reduced in recent years. However, in 2024, an estimated 1.3 million people became newly infected with HIV globally, including 160,000 new HIV infections in the European region. Moreover, in a recent report, the Joint United Nations Programme on HIV and AIDS (UNAIDS) predicted an additional 6 million new HIV infections and 4 million additional AIDS-related deaths worldwide between 2025 and 2029 resulting from the collapse of US funding.

PrEP is a cornerstone of the global HIV response and is highly effective if taken properly. However, access to some PrEP medicines is limited, and adherence is often suboptimal due to various challenges, including the requirement to take a daily pill, stigma, and limited access to healthcare. Consequently, many people at risk for HIV acquisition remain underserved by existing PrEP options, highlighting the urgent need to develop — and distribute — innovative modalities.

The CHMP’s recommendation is based on the results of two randomized, double-blind, active-controlled, multinational trials. In the PURPOSE 1 trial, lenacapavir offered 100% protection against HIV among 5000 women aged 16-25 years in South Africa and Uganda. In the PURPOSE 2 trial, it offered almost complete protection among men and gender-diverse people aged ≥ 16 years who have sex with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the US. In both trials, participants were randomly assigned in a 2:1 ratio to receive twice-yearly subcutaneous injections of lenacapavir or daily oral emtricitabine-tenofovir. 

Earlier this month, the World Health Organization (WHO) released new guidelines recommending the use of lenacapavir as an additional PrEP option for HIV prevention. It labeled lenacapavir as the next best thing to a vaccine and urged governments, donors, and global health partners to begin its rollout immediately within national combination HIV prevention programs.

However, concerns have been raised about its price, with it currently being sold in the US for $28,218 per year. Its manufacturer, Gilead, announced last year that it had signed licensing agreements with six generic manufacturers to allow the production of low-cost versions of the drug for 120 high-incidence, resource-limited countries. 

The CHMP simultaneously reviewed the medicine for non-EU countries under a regulatory procedure called EU-Medicines for all (EU-M4All), which enables the EMA, in collaboration with the WHO, to more quickly make medicines available that address unmet medical needs, or are of major public health interest, in Europe and globally.