Lenacapavir

Gilead Sciences’ Yeytuo^® (lenacapavir), a twice-yearly injectable HIV-1 capsid inhibitor, has received European Commission (EC) approval for pre-exposure prophylaxis (PrEP). This marks the first and only twice-yearly PrEP option available in the EU, plus Norway, Iceland, and Liechtenstein. Backed by Phase 3 PURPOSE 1 and 2 trial data showing high efficacy, the EC decision follows FDA approval and WHO recommendations. This approval aims to address unmet needs in HIV prevention, particularly among vulnerable populations, and accelerate progress toward ending the HIV epidemic in Europe.