European Commission Approves Obicetrapib for Primary Hypercholesterolemia

12:00 AM EDT, 09/22/2026 (MT Newswires) -- The European Commission approved obicetrapib as a treatment for primary hypercholesterolemia, marking the first regulatory approval for the drug worldwide. NewAmsterdam Pharma Co and Menarini Group said Monday that the regulator issued the marketing authorization for 10-milligram monotherapy Ubeslo and the combination formulation Evlarco for both heterozygous familial hypercholesterolemia and non-familial or mixed dyslipidemia. The application for obicetrapib was supported with data from a clinical development program, including results from the phase 3 Broadway, Brooklyn and Tandem trials. A positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use also preceded the approval. NewAmsterdam and Menarini are also developing obicetrapib for cardiovascular applications.