The FDA has approved a labeling update for the injectable LDL-lowering agent inclisiran that expands its indications to include primary prevention for patients with elevated LDL cholesterol.
. The indications now include patients taking statins for primary dyslipidemia who have high-risk comorbidities such as diabetes but who do not have a history of cardiovascular events, the company says.
Inclisiran, with a mechanism of action unique among drugs for dyslipidemia, works by"silencing" RNA involved in the synthesis of proprotein convertase subtilisin/kexin type 9 . The protein helps regulate the number of LDL cell-surface receptors. Novartis says it has"global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals."
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