AstraZeneca Bags Accelerated US Approval for Ultomiris in Kidney Disease IgAN

11:59 PM EDT, 10/21/2026 (MT Newswires) -- AstraZeneca (AZN.L, AZN.ST) secured accelerated approval from the US Food and Drug Administration for Ultomiris to lower proteinuria in adults with primary immunoglobulin A nephropathy, or IgAN, a rare inflammatory disease of the kidney. The authorization was based on the ongoing I CAN late-stage trial evaluating Ultomiris in patients with IgAN at risk of disease progression. A prespecified interim analysis showed that Ultomiris exhibited a 43.4% reduction in proteinuria compared with placebo at 34 weeks, though it has not been determined whether the drug slows kidney function decline. AstraZeneca said Ultomiris' continued approval for IgAN in the US may be subject to the verification and description of its clinical benefit in the I CAN study. The company's regulatory applications for Ultomiris, backed by the I CAN data, are also under review in Japan and other countries.