FDA Approves AstraZeneca Drug for Rare Kidney Disease
The US Food and Drug Administration granted accelerated approval for AstraZeneca drug Ultomiris to treat adults with a rare kidney disease. The treatment significantly reduced excess protein in urine during clinical trials.
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ASTRAZENECA PLC secured accelerated U.S. Food and Drug Administration approval for Ultomiris to treat adults with immunoglobulin A nephropathy, a rare kidney disease. The treatment reduced excess urine protein by 43.4% compared with a placebo during an interim analysis at 34 weeks. The clearance positions the drug as the first and only approved C5 inhibitor for the condition, targeting immune-system pathways linked to kidney inflammation.
