EU Approves NewAmsterdam-Menarini's Obicetrapib in Global First
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Florence – September 21, 2026 -- The European Commission has granted marketing authorization for Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (obicetrapib 10 mg plus ezetimibe 10 mg fixed-dose combination), marking the first global regulatory approval of obicetrapib for NewAmsterdam Pharma (Nasdaq: NAMS) and partner Menarini Group.
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The approval covers primary hypercholesterolaemia, including both heterozygous familial hypercholesterolaemia and non-familial or mixed dyslipidaemia. It follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use and stands as the first regulatory clearance of obicetrapib anywhere in the world.