AstraZeneca's Ultomiris Gets USFDA Approval for Rare Kidney Disease
Bengaluru: AstraZeneca said on Wednesday the US Food and Drug Administration granted accelerated approval for its treatment for adults with immunoglobulin A nephropathy, a rare kidney disease that can lead to renal failure.
AstraZeneca said the treatment Ultomiris reduced proteinuria - excess protein in the urine - by 43.4% compared with placebo after 34 weeks in an interim analysis of the late-stage trial
The drugmaker said the FDA granted the approval under its accelerated pathway, and that the ongoing trial will continue through 106 weeks to determine whether Ultomiris slows loss of kidney function to support traditional approval
The company also said the drug was the first and only approved C5 inhibitor for the disease, targeting an immune-system pathway linked to kidney inflammation
AstraZeneca said more than 200,000 people in the United States have the condition, and about half of those with elevated urine protein levels or reduced kidney function are at high risk of kidney failure within 10 years
The company said no new safety concerns were identified in the study and applications are also under review in Japan and other countries.
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