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FDA Approves Leqvio (inclisiran), First-in-Class siRNA to Reduce Low-Density Lipoprotein Cholesterol (LDL-C) Drugs
December 27, 2021
Novartis today announced the US Food and Drug Administration (FDA) approval of Leqvio® (inclisiran), the first and only small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol...
FDA approves add-on therapy to lower cholesterol among certain high-risk adults FDA
December 23, 2021
FDA has approved Leqvio (inclisiran) injection as a treatment to be used along with diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH)...
Novartis shifts Leqvio manufacturing to Austrian facility cphi-online
July 08, 2021
Pharma firm tells FDA tech transfer to its own facility in Schaftenau, Austria is underway after regulator highlighted concerns about third party CDMO site in Italy
Novartis to manufacture anti-cholesterol drug Leqvio for US in Austria due to delay in US clearance expresspharma
July 07, 2021
US clearance stalled after the US FDA questioned "unresolved facility inspection-related conditions" at the Italian plant of Novartis supplier Corden Pharma.
Novartis’ cholesterol med Leqvio wins EU approval pharmatimes
December 15, 2020
Swiss pharma company Novartis’ cholesterol-lowering drug Leqvio (inclisiran) has been granted approval from the European Commission (EC) for the treatment of primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidaemia.