Posted by Michael Wonder on 03 Sep 2025
Menarini Group's obicetrapib and obicetrapib/ezetimibe marketing authorisation applications accepted for review by the EMA for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia
2 September 2025 - Menarini today announced that EMA has validated the marketing authorisation application for obicetrapib, a selective cholesteryl ester transfer protein inhibitor, and obicetrapib/ezetimibe fixed dose combination as an adjunct to diet for patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia and unable to reach low-density lipoprotein cholesterol goals with the maximum tolerated dose of a statin or who are statin-intolerant, or for whom a statin is contraindicated.
The validation of both applications confirms that the submission is complete and begins the EMA's centralised review procedure.
