Positive CHMP Opinion for NewAmsterdam Pharma and Menarini's Cardiovascular Drugs

NewAmsterdam Pharma and Menarini Group have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Ubeslo® and Evlarco®. These drugs target patients with primary hypercholesterolemia, showing significant improvements in LDL-C reduction in Phase 3 trials. The European Commission's decision on marketing authorization is anticipated in the second half of 2026.

The positive CHMP opinion highlights the efficacy and tolerability of obicetrapib, a novel CETP inhibitor, when administered as monotherapy and in combination with ezetimibe. If approved, these oral treatments could fill a therapeutic gap for patients struggling with existing cholesterol-lowering therapies.

Menarini holds exclusive commercialization rights in Europe, while NewAmsterdam expects royalties and milestone payments. This partnership aims to provide patients with effective solutions to manage cardiovascular risks more effectively.