NewAmsterdam Pharma and Menarini Group said the European Commission approved Ubeslo, obicetrapib 10 mg monotherapy, and Evlarco, a fixed-dose combination of 10 mg obicetrapib and 10 mg ezetimibe. The medicines are authorized for primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia and non-familial or mixed dyslipidaemia. The decision is the first regulatory approval worldwide for obicetrapib and follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use. Phase 3 BROADWAY, BROOKLYN and TANDEM trials showed statistically significant LDL-C reductions of up to 40% with obicetrapib alone and about 50% with the ezetimibe combination, with tolerability comparable to placebo. Menarini has exclusive European commercialization rights and will handle regional regulatory and commercial activities, while NewAmsterdam is eligible for tiered double-digit royalties and up to an additional €833 million in clinical, regulatory and commercial milestones. Obicetrapib is an oral, low-dose CETP inhibitor being studied in several Phase 3 programs, including the PREVAIL cardiovascular outcomes trial, which randomized more than 9,500 patients. The companies said they intend to advance availability across Europe while continuing development, subject to the risks described in NewAmsterdam's forward-looking statements.