Daiichi Sankyo says EMA validated lipid drug filings

Daiichi Sankyo said the European Medicines Agency has validated two EU marketing authorization applications for oral single-pill triple-combination lipid-lowering therapies.

The applications seek approval for adults with primary hypercholesterolemia or mixed dyslipidemia to reduce LDL cholesterol levels and cardiovascular risk.

The company said the applications cover bempedoic acid with ezetimibe and atorvastatin, and bempedoic acid with ezetimibe and rosuvastatin. It said multiple statin dose options are intended to allow treatment to be tailored to individual patients.

Daiichi Sankyo said the proposed therapies could become the first oral single-pill triple-combinations for lipid-lowering in the EU if approved.