AstraZeneca Adds New Indication for Ultomiris Drug in Rare Kidney Disease
Dow Jones10-22
AstraZeneca said it received U.S. approval for its Ultomiris drug as a treatment for foamy urine in adults with immunoglobulin A nephropathy, a rare condition that can lead to chronic kidney disease.
The U.K. drugmaker said late Wednesday that the latest Ultomiris approval was based on reduction of the so-called proteinuria--elevated protein levels in urine--in adult IgAN patients. The medicine is authorized in the U.S. for a range of rare diseases, including primary IgAN.
The U.S. Food and Drug Administration granted accelerated approval based on the results of a late-stage study that remains under way, and continued approval might be contingent upon verification of clinical benefit, the company added.
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