FDA Approves Novartis Drug That Will Go Up Against PCSK9s

February 10

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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Radar on Specialty Pharmacy

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.