NewAmsterdam Pharma and Menarini receive positive CHMP opinion for cholesterol treatments

NewAmsterdam Pharma and its partner, the Menarini Group, have received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). This recommendation supports the marketing authorization of Ubeslo® (obicetrapib monotherapy) and Evlarco® (a fixed-dose combination of obicetrapib and ezetimibe) in Europe. The treatments are intended for patients with primary hypercholesterolemia and mixed dyslipidemia.

The CHMP's recommendation is based on positive results from the Phase 3 clinical trials BROADWAY, BROOKLYN, and TANDEM. These studies demonstrated that obicetrapib, as monotherapy, significantly reduced LDL-cholesterol by up to 40% compared to placebo. In combination with ezetimibe, the reduction reached approximately 50% compared to placebo, with a tolerability profile similar to placebo.

The European Commission is expected to make a final decision on the marketing authorization in the second half of 2026. If approved, the authorization will be valid across all EU member states, as well as Iceland, Liechtenstein, and Norway. The Menarini Group holds the exclusive rights to market obicetrapib in Europe.

NewAmsterdam Pharma is a biopharmaceutical company focused on developing non-statin oral therapies for patients with elevated LDL-cholesterol who have an unmet need with existing treatments. The company is also progressing with the PREVAIL cardiovascular outcomes trial, a significant Phase 3 study evaluating obicetrapib's potential to reduce major adverse cardiovascular events.