Posted by Michael Wonder on 19 Aug 2025
NewAmsterdam announces acceptance of marketing authorisation applications for review by EMA for obicetrapib
18 August 2025 - NewAmsterdam Pharma today announced that the EMA has validated the marketing authorisation application for obicetrapib 10 mg monotherapy and 10 mg obicetrapib and 10 mg ezetimibe fixed dose combination for patients with primary hypercholesterolemia, both heterozygous familial and non-familial or mixed dyslipidaemia.
The marketing authorisation application were submitted by NewAmsterdam’s partner Menarini, who is responsible for communications with regulatory authorities in Europe and for the commercialisation and local development of obicetrapib in Europe and other collaborative activities pursuant to an exclusive license agreement.
