Medical Technology

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

The US Food and Drug Administration (FDA) has approved inclisiran Leqvio as an addition to statins to aid in further reducing LDL cholesterol. Novartis, the drug’s inventor, announced today.

The first-in-class small interferingRNA (siRNA) agent is also unique in peer-to-peer treatment options. It can be administered by injection at three months, and then two times every year.

Inclisiran is indicated for use on top of statins that are well tolerated by adults suffering from cardiovascular disease or with heterozygous familial hypercholesterolemia (HeFH) according to the company announced.

Patients who received inclisiran in comparison to placebo in the ORION-9 and ORION-10 randomized studies upon which FDA approval was based showed LDL C reductions that exceeded 50% in just one to 2 years.

The drug “silencing” the RNA involved in the synthesis of PCSK9 that is responsible for controlling the LDL-cell-surface receptors. This is a distinct mechanism of dyslipidemia treatment.

Novartis, the company said, “has obtained global rights to develop, manufacture, and commercialize Leqvio in accordance with a license and collaboration agreement with Alnylam Pharmaceuticals.”

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