EMA Accepts Menarini Group’s Applications for Obicetrapib and Obicetrapib/Ezetimibe to Treat Primary Hypercholesterolemia

The European Medicines Agency (EMA) has accepted the marketing authorization applications for obicetrapib and the combination therapy obicetrapib/ezetimibe, submitted by Menarini Group. These treatments are intended for adult patients diagnosed with primary hypercholesterolemia, including both heterozygous familial and non-familial forms.

Obicetrapib is a therapeutic agent designed to address elevated cholesterol levels, while the combination therapy pairs obicetrapib with ezetimibe to enhance its efficacy. The acceptance of these applications marks a step forward in the regulatory review process, which will evaluate the safety, efficacy, and quality of these medications for potential approval in Europe.

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Source: GO-AI-ne1

Date: September 2, 2025

Author

Mark Chiang