NewAmsterdam Pharma and Menarini's Obicetrapib Receives EMA Validation for Marketing Authorization Applications in Europe

Reuters
08/18
NewAmsterdam Pharma and Menarini's Obicetrapib Receives EMA Validation for Marketing Authorization Applications in Europe

NewAmsterdam Pharma Company N.V. has announced that the European Medicines Agency $(EMA)$ has validated the Marketing Authorization Applications $(MAA)$ for their drug obicetrapib. The applications cover both the 10 mg monotherapy and the 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination, targeting patients with primary hypercholesterolemia, including both heterozygous familial and non-familial forms, as well as mixed dyslipidemia. These submissions, made by NewAmsterdam's partner A. Menarini International Licensing S.A., mark a significant step in the regulatory review process. Menarini is responsible for regulatory communications, commercialization, and local development within Europe, under an exclusive license agreement with NewAmsterdam. The company is entitled to tiered double-digit royalties on net sales in the Menarini Territory and stands to achieve additional financial milestones upon successful regulatory and commercial progress.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. NewAmsterdam Pharma Company NV published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9513723-en) on August 18, 2025, and is solely responsible for the information contained therein.

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