NewAmsterdam Pharma and Menarini have received a favorable opinion from the CHMP regarding their cholesterol-lowering treatments, obicetrapib and its combination with ezetimibe, paving the way for potential commercialization in Europe.
This positive recommendation is founded on robust data from Phase 3 clinical trials—BROADWAY, BROOKLYN, and TANDEM—demonstrating significant reductions in low-density lipoprotein cholesterol (LDL-C). Specifically, obicetrapib monotherapy showed up to a 40% decrease in LDL-C compared to placebo, while the combination with ezetimibe achieved around a 50% reduction. The CHMP's opinion will now be reviewed by the European Commission, with a decision anticipated in the second half of 2026.
Michael Davidson, CEO of NewAmsterdam, emphasized the importance of this milestone, noting the therapy's potential to address unmet needs for patients struggling to achieve LDL-C targets with existing treatments. Menarini's CEO, Elcin Barker Ergun, expressed optimism about the collaboration and the drug's unique mechanism of action.
The ongoing Phase 3 PREVAIL trial aims to further assess obicetrapib's cardiovascular outcomes, addressing the significant global burden of cardiovascular disease, which remains a leading cause of mortality. Despite the availability of lipid-lowering therapies, many patients do not reach their LDL-C goals, highlighting the necessity for innovative solutions like obicetrapib.