NewAmsterdam and Menarini gain EU backing for cholesterol drug

The Committee for Medicinal Products for Human Use (CHMP) endorsed the drugs based on results from the Phase 3 BROADWAY, BROOKLYN, and TANDEM trials. Data indicated that obicetrapib monotherapy could reduce LDL-C levels by up to 40%, while the combination of obicetrapib and ezetimibe achieved reductions of approximately 50% compared to a placebo. Participants reported a tolerability profile comparable to the placebo group, bolstering the case for the oral, once-daily treatment.

Following the CHMP recommendation, the European Commission is expected to make a final decision on marketing authorization in the second half of 2026. If approved, Menarini will handle commercialization across the European Union, Iceland, Liechtenstein, and Norway. NewAmsterdam Pharma stands to receive tiered double-digit royalties on net sales, alongside potential milestone payments reaching 833 million euros. The companies continue to monitor long-term outcomes through ongoing studies, including the PREVAIL cardiovascular trial, which recently completed enrollment of over 9,500 patients.