FDA Approves Novartis Drug That Will Go Up Against PCSK9s
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Feb 10, 2022
More than a year after pandemic travel restrictions pushed back the FDA’s approval decision on Novartis Pharmaceuticals Corp.’s inclisiran, the agency finally approved it. The new first-in-class therapy targets so-called bad cholesterol and is set to compete with two other biologics that target the same protein.
On Dec. 22, the FDA approved Leqvio as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-c).
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