It's a year late, but Novartis has finally steered inclisiran to FDA approval. Will it sell?
The centerpiece of Novartis’s $9.7 billion buyout of the Medicines Company can finally go to market.
Branded Leqvio, the small interfering RNA therapy long known as inclisiran is the first and only FDA-approved treatment to reduce LDL-C, i.e. bad cholesterol, with just two maintenance doses a year after an initial dose and another one at three months.
Touting a “revolutionary approach,” Novartis CEO Vas Narasimhan noted that the approval “creates new possibilities for how healthcare systems can impact cardiovascular disease, a defining public health challenge of our time.” The label covers both atherosclerotic cardiovascular disease and heterozygous familial hypercholesterolemia.
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