Biopharmaceutical company Gilead Sciences Inc (Nasdaq:GILD) announced on Tuesday that the European Commission has granted marketing authorization for Yeytuo (lenacapavir), a twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP).

This approval makes Yeytuo the first and only PrEP option in the European Union and European Economic Area offering six months of protection.

The decision follows an accelerated review by the European Medicines Agency's Committee for Medicinal Products for Human Use, which deemed the product of major public health interest. Lenacapavir also received one additional year of EU market protection after being recognized as providing significant clinical benefit compared with existing therapies.

The authorization is supported by data from two Phase 3 trials, PURPOSE 1 and PURPOSE 2, which demonstrated superior HIV prevention compared with once-daily Truvada. Across both trials, lenacapavir showed near-complete protection against HIV infection and was well tolerated.

Yeytuo's approval comes shortly after US Food and Drug Administration authorization in June and new World Health Organization guidance in July recommending twice-yearly lenacapavir as a PrEP option. Gilead is also advancing regulatory filings in multiple countries, including Australia, Brazil, Canada, South Africa, and Switzerland.

To expand global access, Gilead is preparing submissions in Argentina, Mexico, and Peru, and will leverage the EU-Medicines for all procedure to accelerate reviews in low- and middle-income countries. In addition, Gilead has partnered with The Global Fund to potentially supply lenacapavir for up to two million people in lower-income regions, subject to local approvals.