ET 16:03

NewAmsterdam Pharma Wins EU Approval for Obicetrapib Cholesterol Drugs Ubeslo, Evlarco

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Regulatory

NewAmsterdam Pharma (NAMS) and partner Menarini Group said the European Commission granted marketing authorization on Sept. 21, 2026, for Ubeslo (obicetrapib monotherapy) and Evlarco (obicetrapib plus ezetimibe) for adults with primary hypercholesterolemia. The decision marks the first global regulatory approval for the obicetrapib franchise. The approvals cover the European Union, positioning the oral, once-daily CETP inhibitor as a new option for patients whose LDL cholesterol remains elevated despite standard statin therapy. NewAmsterdam has not disclosed EU launch timing or pricing. The company is also pursuing U.S. regulatory review of obicetrapib as it seeks to enter the multi-billion-dollar lipid-lowering market.

EditorTan Wei Jie