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.
EU regulators authorize first CETP inhibitor for elevated LDL-C
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.
Phase 3 data show up to 50% LDL-C reduction with combination therapy
The clearance rests on results from the Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which recorded LDL-C reductions of up to 40% for obicetrapib monotherapy versus placebo and approximately 50% for the ezetimibe combination versus placebo. Tolerability in both regimens matched placebo levels, according to the companies.
Menarini secures exclusive European commercialization rights
Under the existing licensing agreement, Menarini holds exclusive rights to commercialize obicetrapib across Europe and will lead regulatory interactions and market rollout in the region. NewAmsterdam is entitled to tiered double-digit royalties, ranging from low double-digits to the mid-twenties, on net sales in Menarini's territory, plus up to €833 million in additional milestone payments tied to clinical, regulatory and commercial targets.
CEO calls the clearance validation for years of clinical work
"This first-in-class approval reflects the strength of the clinical evidence supporting obicetrapib, the dedication of our team and partners, and our commitment to addressing one of the largest unmet needs in cardiovascular medicine," said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma. Menarini Chief Executive Officer Elcin Barker Ergun said the company will draw on its established cardiovascular commercial infrastructure to bring the two products to healthcare providers across Europe.
Additional Phase 3 programs continue, including a 9,500-patient outcomes trial
NewAmsterdam and Menarini are advancing further Phase 3 studies of obicetrapib, including the PREVAIL cardiovascular outcomes trial, which completed enrollment of more than 9,500 patients in April 2024, alongside the REMBRANDT and RUBENS trials.