New Amsterdam Says EMA Accepts Application for Obicetrapib Therapy for Treating Hypercholesterolemia

MT Newswires Live

Aug 18

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.

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