Japanese healthcare company Daiichi Sankyo Co Ltd (TYO:4568) announced on Thursday that it has received European Medicines Agency (EMA) validation for two marketing authorisation applications covering single-pill triple-combination therapies designed to lower cholesterol and cardiovascular risk in adults with primary hypercholesterolaemia or mixed dyslipidaemia.
The proposed treatments combine bempedoic acid and ezetimibe with either atorvastatin or rosuvastatin, with multiple statin dosage options intended to accommodate individual patient needs.
If approved, the therapies could become the first oral single-pill triple combinations for lipid lowering in the European Union, aiming to simplify treatment and improve medication adherence among patients requiring multiple therapies.
The applications address persistent challenges in lipid management, as many high- and very-high-risk patients do not achieve recommended low-density lipoprotein cholesterol (LDL-C) targets, partly because of the complexity and pill burden associated with multiple medications.
Professor Klaus G. Parhofer of the University of Munich said the combinations could offer a simplified treatment approach for patients requiring intensified cholesterol management, including those with diabetes.
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