NewAmsterdam announces acceptance of MAA for review by EMA for obicetrapib

NewAmsterdam Pharma (NAMS) Company N.V. announced that the European Medicines Agency, EMA, has validated the Marketing Authorization Application, MAA, for obicetrapib 10 mg monotherapy and 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination, FDC, for patients with primary hypercholesterolemia, both heterozygous familial, HeFH, and non-familial or mixed dyslipidemia. The MAAs were submitted by NewAmsterdam’s partner, A. Menarini International Licensing S.A., who is responsible for communications with regulatory authorities in Europe and for the commercialization and local development of obicetrapib in Europe and other collaborative activities pursuant to an exclusive License Agreement.