Overview

• The decision authorizes commercialization of Yeytuo across the European Union after a positive EMA CHMP opinion in July.
• Yeytuo is administered as two injections per year, a long-acting approach intended to improve real-world protection compared with daily oral PrEP.
• Company-run trials reported a reduction in HIV acquisition of more than 99.9% among adults and adolescents.
• Gilead has not disclosed European pricing; the company set a U.S. list price above $28,000 per patient-year, prompting access concerns from experts and advocates.
• The drug is branded Yeztugo in the United States, which approved it in June, and access in low- and middle-income countries is expected to rely on a 2024 generics deal and a Global Fund procurement contract.