NewAmsterdam and Menarini get positive EU CHMP opinion for obicetrapib medicines

On July 24, 2026, NewAmsterdam Pharma announced that the CHMP of the EMA issued a favorable opinion supporting marketing authorization in Europe for Ubeslo, a 10 mg obicetrapib monotherapy, and Evlarco, a fixed-dose combination of 10 mg obicetrapib and 10 mg ezetimibe, for patients with primary hypercholesterolemia, covering both heterozygous familial and non-familial or mixed dyslipidemia cases.¹

The committee's recommendation draws on clinical data from the Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which showed LDL-C reductions of as much as 40% for obicetrapib alone compared with placebo, and roughly 50% when obicetrapib was paired with ezetimibe, also versus placebo, with side effects similar to those seen with placebo.¹

The two companies are continuing to test obicetrapib in additional Phase 3 work, including the PREVAIL cardiovascular outcomes study along with the REMBRANDT and RUBENS trials.¹

The CHMP opinion now moves to the European Commission, which has the authority to grant a centralized marketing authorization covering all EU member states plus Iceland, Liechtenstein and Norway, and is expected to issue a final decision.¹ The release states that this EC decision is anticipated in the second half of 2026.

Under the existing partnership, Menarini holds exclusive rights to commercialize obicetrapib in Europe and handles regulatory matters and commercial activities across the region.¹ In return, NewAmsterdam is set to receive tiered royalties on net sales in Menarini's territory, ranging from low double digits to the mid-twenties percentage-wise, plus as much as an additional €833 million tied to clinical, regulatory and commercial milestones.¹