Novartis plans for potential accelerated approval for kidney disease drug after PhIII interim analysis result
Novartis’ rare kidney disease drug, which it acquired in a $3.2 billion purchase of Chinook Therapeutics in June, met the primary endpoint of a Phase III study after an interim analysis, the company announced Monday.
Atrasentan, an oral endothelin A receptor antagonist, demonstrated “superiority” against placebo at a 36-week interim analysis in the 340-patient ALIGN study in patients with IgA nephropathy (IgAN), a progressive and rare kidney disease that largely impacts young adults. IgAN is a major cause of chronic kidney disease and kidney failure as it progresses.
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