FDA Accelerated Approval for Ultomiris in Adult IgAN

AstraZeneca reported that the US Food and Drug Administration has granted accelerated approval for Ultomiris (ravulizumab) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

According to AstraZeneca, Ultomiris is the first and only C5 complement inhibitor approved in the US for this purpose. The indication received Priority Review and was approved under the accelerated approval pathway based on reduction of proteinuria.

Interim Phase III evidence supported the decision

AstraZeneca said the approval was supported by a prespecified interim analysis of the ongoing I CAN Phase III trial. At 34 weeks, Ultomiris demonstrated a 43.4% placebo-adjusted reduction in proteinuria.

In the analysis, 24-hour urine protein creatinine ratio declined 46.6% from baseline among patients receiving Ultomiris, compared with a 5.6% reduction among patients receiving placebo. AstraZeneca reported that the proteinuria reduction was observed as early as week 10 and was sustained through week 34.

The company said the observed safety profile was consistent with the known profile of Ultomiris and that no new safety concerns were identified in the interim results.

Ongoing study will assess kidney-function endpoint

AstraZeneca noted that it has not been established whether Ultomiris slows kidney function decline in patients with IgAN. Continued approval may be contingent on verification and description of clinical benefit in the ongoing I CAN trial.

The study is evaluating change from baseline in estimated glomerular filtration rate at week 106, with data intended to support traditional FDA approval. AstraZeneca described I CAN as a global, Phase III, randomised, double-blind, placebo-controlled trial in adults with IgAN at risk for disease progression.

Ultomiris is administered intravenously every eight weeks in adults following a loading dose, according to AstraZeneca. The company said late-breaking I CAN results are scheduled for presentation at the American Society of Nephrology’s Kidney Week on 23 October 2026.

Commercial and clinical context

For medical-device and specialty-care sales professionals, the approval adds a complement-inhibition option to the IgAN care landscape, where proteinuria is a key clinical measure. AstraZeneca stated that IgAN is a rare inflammatory kidney disease that can progress to chronic kidney disease and end-stage kidney disease.

AstraZeneca also reported that regulatory submissions based on the interim I CAN results are under review in Japan and additional countries.