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StocksMedium•21 October 2026•
2 min read

Ultomiris cuts urine protein by 43.4% as AstraZeneca seeks expanded use in kidney disease

Key Facts

1Ultomiris reduced protein in the urine by 43.4% compared with placebo at week 34 in the trial's interim analysis.
2More than 217,000 people in the United States have been diagnosed with immunoglobulin A nephropathy, according to AstraZeneca.
3The Ultomiris trial includes measuring the change in estimated glomerular filtration rate at week 106 to assess kidney function.
4AstraZeneca had expected a U.S. decision on the drug's expanded use in the fourth quarter of 2026.

AstraZeneca said Ultomiris reduced protein in the urine by 43.4% compared with placebo in an interim analysis of the I CAN trial in adults with immunoglobulin A nephropathy. The result was recorded at week 34 of the trial, which also includes longer-term monitoring of kidney function. The company said the U.S. Food and Drug Administration had accepted its supplemental biologics license application for the drug and granted it priority review for this use. The application seeks to expand the use of Ultomiris, known generically as ravulizumab, to treat adults with the kidney disease. The drug received its first U.S. approval in 2018, according to its FDA-approved label.

AstraZeneca says more than 217,000 people in the United States have been diagnosed with immunoglobulin A nephropathy. The disease arises when abnormal forms of this immunoglobulin develop, according to the company's description of the disease mechanism. These proteins lead to the formation of immune complexes that deposit in the kidneys and cause damage. Jonathan Barratt, an investigator in the I CAN trial, said "activation of the terminal complement pathway is a key driver of inflammation and progressive loss of kidney function" in people with the disease. The trial examines treatment in adults, the population targeted by the application for expanded use submitted to the U.S. regulator.

On safety, AstraZeneca said the trial's interim analysis identified no new concerns. The approved Ultomiris label, however, carries a warning of an increased risk of serious and life-threatening meningococcal infections. In the competitive treatment landscape, Novartis said its drug Fabhalta slowed the decline in estimated glomerular filtration rate by 48% compared with placebo over two years, a result related to preserving kidney function. For rival drug Voyxact, the FDA said accelerated approval was based on reducing protein in the urine. The agency said "it has not been established whether Voyxact slows the long-term decline in kidney function in patients with immunoglobulin A nephropathy."

The I CAN trial was designed to enroll about 510 participants, according to AstraZeneca. Its targeted geographical reach spans 28 countries. These countries are spread across North America, South America, Europe, Asia and Australia. Follow-up includes measuring the change in estimated glomerular filtration rate at week 106 to assess kidney function. On the regulatory front, AstraZeneca had expected an FDA decision on the application to expand the use of Ultomiris in the fourth quarter of 2026.