Leqvio Approved as Adjunct Therapy to Lower Cholesterol

Caplyta Approved to Treat Bipolar Depression
December 20, 2021
Cosentyx Receives New and Expanded Pediatric Indications
December 22, 2021
Caplyta Approved to Treat Bipolar Depression
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Cosentyx Receives New and Expanded Pediatric Indications
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December 22, 2021 – Leqvio® (inclisiran) is now FDA approved for use as an adjunct to diet and maximally tolerated statin therapy to treat adults who have heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease and require additional lowering of low-density lipoprotein cholesterol (LDL-C).

  • The drug is the first and only small interfering RNA therapy to receive FDA approval for lowering LDL-C. Like Praluent® (alirocumab – Regeneron) and Repatha® (evolocumab – Amgen), it inhibits PCSK9, a protein that can contribute to high LDL-C levels.
  • Recommended dosing is 284mg given by a healthcare provider via subcutaneous injection, with the first two doses given three months apart and subsequent doses given once every six months.
  • Manufactured by Novartis, Leqvio has launched at a wholesale acquisition cost of $3,250 per syringe.