AstraZeneca says FDA approves drug for rare kidney disease in adults
AZN•AstraZeneca said the FDA granted accelerated approval for Ultomiris to treat adults with immunoglobulin A nephropathy. The drug reduced proteinuria by 43.4% versus placebo after 34 weeks in an interim analysis.
1. Accelerated approval
AstraZeneca said the FDA approved Ultomiris for adults with immunoglobulin A nephropathy, a rare kidney disease that can lead to renal failure. The drug targets a complement-system pathway linked to kidney inflammation and is the first and only approved C5 inhibitor for the disease, the company said.
2. Trial and review
In an interim analysis of a late-stage trial, Ultomiris reduced proteinuria by 43.4% compared with placebo after 34 weeks. The trial will continue through 106 weeks to determine whether the treatment slows loss of kidney function to support traditional approval. AstraZeneca said no new safety concerns were identified, and applications are under review in Japan and other countries.
