FDA Approves First-in-Class Inclisiran to Lower LDL-C


The US Food and Drug Administration (FDA) has approved inclisiran (Leqvio) as an adjunct to statins for further reduction of LDL cholesterol levels, the drug’s developer, Novartis, announced today.

The first-in-class small interfering RNA (siRNA) agent is also novel among peer drug therapies for its administration by injection initially, at three months, and thereafter twice per year.

Inclisiran is indicated for use atop maximally tolerated statins in adults with clinical cardiovascular disease or in patients with heterozygous familial hypercholesterolemia, the company reported.

Such patients who received inclisiran, compared with placebo, in the ORION-9, ORION-10, and ORION-11 randomized trials on which the FDA approval was based showed LDL-C reductions exceeding 50% over 1 to 2 years.

The drug works by “silencing” RNA involved in synthesis of PCSK9, which has 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 global rights to develop, manufacture, and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”

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