THOUSAND OAKS (dpa-AFX) - Amgen Inc. (AMGN) Tuesday said it has filed a Marketing Authorization Application or MAA to the European Medicines Agency or EMA through the centralized procedure for evolocumab, seeking approval for the treatment of high cholesterol.
Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove bad cholesterol from the blood.
The MAA for evolocumab contains data from ten Phase 3 trials, that assesed the safety and efficacy of evolocumab in patients with elevated cholesterol on statins with or without other lipid-lowering therapies.
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