NewAmsterdam Pharma (NAMS) said Monday the European Medicines Agency validated the marketing authorization application for obicetrapib as a monotherapy and in combination with ezetimibe for adults with primary hypercholesterolemia or mixed dyslipidemia.

The submissions are supported by data from phase 3 trials showing LDL cholesterol reduction of 35% to 40% with obicetrapib and about 50% in combination with ezetimibe, compared with placebo, the company said.

The applications were submitted by NewAmsterdam's partner Menarini which is responsible for developing and commercializing the therapy in Europe.