Skip to main content

Posts

Showing posts with the label Norvatis

Inclisiran (siRNA) for the Treatment of Hypercholesterolemia: PDUFA Date Set as December 2020

Highlights of Inclisiran Program - Inclisiran, an investigational cholesterol-lowering therapy, was added to the pipeline from the Novartis acquisition of The Medicines Company.  - Inclisiran recently received a positive CHMP opinion and recommendation for marketing authorization in Europe and is under review by the US Food and Drug Administration - Pooled data analyses from Phase III ORION-9, -10 and -11 showed that inclisiran consistently reduced low-density lipoprotein cholesterol (LDL-C) by approximately 51% in both male and female adult patients and in three age categories - Expected Approvals by End of 2020 or H1 2021 Inclisiran is a double-stranded siRNA, conjugated with GalNAc allowing for targeted uptake by hepatocytes. In hepatocytes, inclisiran silences PCSK9 expression, increasing LDL-C receptor recycling and expression on the hepatocyte cell surface, thereby increasing LDL-C uptake by hepatocytes and lowering LDL-C levels in the circulation. Inclisiran (ALN-PCSsc) is a...