The US Food and Drug Administration (FDA) has approved Inclisiran (Leqvio) as an additive to statins to further lower LDL cholesterol levels, the drug’s developer, Novartis, announced today.
The first-in-class drug for small interfering RNA (siRNA) is also new among peer drug therapies for its administration by injection, initially after three months and then twice a year.
Inclisiran is indicated for use in addition to maximally tolerated statins in adults with clinical cardiovascular disease or in patients with heterozygous familial hypercholesterolaemia, the company reported.
These patients who received inclisiran in the randomized studies ORION-9, ORION-10 and ORION-11, on which the FDA approval was based, showed an LDL-C reduction of more than 50% over 1 to compared to placebo 2 years.
The drug works by “silencing” the RNA involved in the synthesis of PCSK9, which plays a role in controlling the number of LDL cell surface receptors, a unique mechanism of action among available treatments for dyslipidemia.
Novartis, the company said, “has obtained worldwide rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”
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