NewAmsterdam Pharma and Menarini Receive First Obicetrapib Approval Worldwide: European Commission Approves Ubeslo and Evlarco for Primary Hypercholesterolemia
NewAmsterdam Pharma and Menarini Group announced on Monday, September 21, 2026 that the European Commission approved Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib 10 mg plus ezetimibe 10 mg) for adults with primary hypercholesterolemia, including heterozygous familial and non-familial forms, or mixed dyslipidemia. The companies called it the first regulatory approval of obicetrapib, an oral, low-dose CETP inhibitor, anywhere in the world. The approval cites the Phase 3 BROADWAY, BROOKLYN, and TANDEM trials, which showed LDL-C reductions of up to 40% with obicetrapib alone and about 50% with the ezetimibe combination versus placebo, with tolerability comparable to placebo. Menarini holds exclusive European commercialization rights and pays NewAmsterdam tiered double-digit royalties, with up to €833 million more in milestones.