AstraZeneca's Ultomiris Wins FDA Approval to Reduce Proteinuria in IgAN Patients

04:32 AM EDT, 10/22/2026 (MT Newswires) -- AstraZeneca's (AZN) Alexion unit's Ultomiris received the US Food and Drug Administration accelerated approval to reduce proteinuria in adults with primary IgA nephropathy at risk of disease progression, the company said late Wednesday. The approval was based on a prespecified interim analysis of the phase III I CAN trial, which showed Ultomiris reduced proteinuria by 43.4% versus placebo at 34 weeks. The treatment is administered intravenously every eight weeks following a loading dose. The ongoing trial will assess kidney function at week 106 to support potential traditional FDA approval, with late-breaking results due Oct. 23 at the American Society of Nephrology's Kidney Week, the company added.