NewAmsterdam Pharma announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for obicetrapib 10 mg monotherapy and its 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination (FDC). These applications were submitted by NewAmsterdam’s partner, A. Menarini International Licensing S.A.
The MAAs are for the treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia. This validation marks a significant step forward in the regulatory process, allowing for the review of pivotal Phase 3 trials, including BROADWAY, BROOKLYN, and TANDEM.
Under the Menarini License, NewAmsterdam Pharma is eligible to receive tiered double-digit percentage royalties ranging from the low double-digits to mid-twenties on net sales in the Menarini Territory. The company is also eligible for up to an additional €833 million upon the achievement of various clinical, regulatory, and commercial milestones, with €30 million already received to date.
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