Naarden, Netherlands; Florence, Italy; and Miami, U.S., September 21, 2026

NewAmsterdam Pharma and Menarini Group have reached a major cardiovascular medicine regulatory milestone after the European Commission granted marketing authorization for Ubeslo® (obicetrapib 10 mg) and Evlarco® (obicetrapib 10 mg plus ezetimibe 10 mg). The approvals cover adults with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, as well as non-familial or mixed dyslipidaemia. The decision represents the first regulatory approval of obicetrapib worldwide, establishing a new treatment option based on a low-dose oral CETP inhibitor for patients requiring additional LDL-cholesterol lowering. The European authorization follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is supported by data from several Phase 3 clinical trials.

European Commission Approves Two Obicetrapib Medicines

The European Commission authorization covers Ubeslo, an obicetrapib monotherapy, and Evlarco, a fixed-dose combination of obicetrapib and ezetimibe. Obicetrapib is an oral, low-dose cholesteryl ester transfer protein (CETP) inhibitor developed by NewAmsterdam Pharma as a non-statin approach to lowering LDL-C. The medicines are intended for patients with elevated cholesterol who require additional LDL-C reduction. According to the companies, the approval was supported by the Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which demonstrated statistically significant LDL-C reductions with obicetrapib and a tolerability profile comparable to placebo. The company reported LDL-C reductions of up to 40% with obicetrapib monotherapy versus placebo and approximately 50% with the obicetrapib-ezetimibe combination versus placebo.

The regulatory milestone is particularly significant because it represents the first worldwide approval for obicetrapib. NewAmsterdam is developing the therapy for patients at risk of cardiovascular disease who have elevated LDL-C levels despite available treatment approaches. The European authorization provides a regulatory pathway for bringing both products to eligible patients across the European market. Under the companies’ licensing agreement, Menarini Group holds exclusive commercialization rights for obicetrapib in Europe and will be responsible for regulatory interactions and commercialization activities across the region.

Phase 3 Evidence Supports LDL-C Reduction

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The European approval follows a broad clinical development program evaluating obicetrapib as both a monotherapy and in combination with ezetimibe. In addition to BROADWAY, BROOKLYN and TANDEM, NewAmsterdam has continued development through additional Phase 3 studies, including PREVAIL, a cardiovascular outcomes trial designed to evaluate whether obicetrapib may reduce major adverse cardiovascular events. The company reported that PREVAIL completed enrollment in April 2024 with more than 9,500 patients randomized, while other Phase 3 programs, including REMBRANDT and RUBENS, remain ongoing. The approval addresses an important area of cardiovascular medicine because elevated low-density lipoprotein cholesterol (LDL-C) is a major modifiable risk factor associated with cardiovascular disease. NewAmsterdam’s development strategy focuses on oral, non-statin therapies for people who do not achieve appropriate LDL-C levels with existing treatments or who require additional lipid-lowering options. The company and Menarini said the European approvals are expected to expand treatment choices for eligible patients across Europe.

With the European Commission decision, Ubeslo and Evlarco become the first approved obicetrapib-containing medicines worldwide. The milestone also moves the program from late-stage clinical development into commercialization in Europe, while NewAmsterdam and Menarini continue to advance additional clinical studies. The companies’ next steps include preparing for commercialization and continuing regulatory and clinical activities surrounding obicetrapib. The approved indications, contraindications, warnings and precautions will be detailed in the products’ European Summary of Product Characteristics.

Source: NewAmsterdam Pharma, Menarini Group press release