22nd Oct 2026 10:24
(Alliance News) - AstraZeneca PLC on Thursday said subsidiary Alexion Pharmaceutical's Ultomiris has received accelerated approval in the US for the treatment of a rare kidney disease called immunoglobulin A nephropathy.
Ultomiris is a medication that reduces protein levels in the urine of adults, who are at risk of disease progression. It works by targeting the C5 protein, part of the human immune system that can contribute to tissue damage.
IgAn affects more than 200,000 people in the US, according to AstraZeneca.
Alexion is a Boston, Massachusetts-based wholly owned subsidiary of Cambridge, England-based pharmaceutical maker AstraZeneca. Alexion focuses on developing medications for the treatment of rare and serious conditions.
AstraZeneca said the approval by the US Food & Drug Administration follows a priority review and is based on interim results from the phase III I Can trial.
In the trials, Ultomiris was found to reduce proteinuria, or excess protein in urine, by more than 43% compared with a placebo at 34 weeks.
Alexion Chief Executive Officer said: "Ultomiris offers a new treatment option for people living with this serious disease. Many patients continue to face the risk of progression to kidney failure, underscoring the need for more targeted therapies that can slow the course of disease. This approval marks the fifth indication for Ultomiris, building on Alexion's pioneering leadership across multiple complement-mediated rare diseases."
Latest results from the I Can trial are due to be presented at the American Society of Nephrology's Kidney Week on Friday.
Shares in AstraZeneca were marginally higher at 12,618.00 pence per share on Thursday morning in London.
By Niall Holden, Alliance News reporter
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