Amgen submits application to FDA for Repatha (evolocumab) Injection monthly version to treat dyslipidaemia.
Amgen announced the submission of an application to the FDA seeking approval of a single-dosing option for the monthly administration of Repatha (evolocumab) Injection, allowing the 420 mg monthly dose to be administered as a single injection. Approved by the FDA on 27 August 2015 , Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.
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