EC approves NewAmsterdam's obicetrapib drugs Ubeslo and Evlarco with Menarini

On September 21, 2026, NewAmsterdam Pharma Company N.V. said the European Commission granted marketing authorization for two obicetrapib-based products developed with partner Menarini Group. The approvals cover Ubeslo, a 10 mg obicetrapib monotherapy, and Evlarco, a fixed-dose combination of 10 mg obicetrapib and 10 mg ezetimibe, for patients with primary hypercholesterolaemia, including heterozygous familial and non-familial forms, as well as mixed dyslipidaemia.¹ NewAmsterdam said this is the first time obicetrapib has received regulatory approval anywhere.

The authorizations cover all European Union member states along with Iceland, Liechtenstein, and Norway.¹

As a condition of approval, the EC requires standard post-approval safety monitoring and risk-minimization steps, plus a post-authorization efficacy study for which the company must submit final results from its PREVAIL cardiovascular outcomes trial, a placebo-controlled, double-blind, randomized study testing obicetrapib monotherapy added to maximally tolerated lipid-lowering therapy in patients with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolaemia.¹

Under the companies' agreement, Menarini has exclusive rights to sell obicetrapib in Europe and handles regulatory matters and commercial activities in that region.¹ In return, NewAmsterdam is set to receive tiered royalties on net sales in the Menarini territory, ranging from low double-digit to mid-twenties percentages, plus up to €833 million tied to clinical, regulatory, and commercial milestones, with the EC's authorizations for both products triggering milestone payments in the mid-teens of millions of euros.¹