Ultomiris approved as first C5 complement inhibitor for primary IgA nephropathy

FDA has granted accelerated approval to Ultomiris (ravulizumab-cwvz) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. Ultomiris is the first and only component 5 (C5) complement inhibitor approved for this indication.

IgAN is a rare, inflammatory disease of the kidneys that can lead to chronic kidney disease and progress to end-stage kidney disease (ESKD). Approximately half of patients with elevated urinary protein levels or reduced kidney function are at high risk of progression to ESKD within 10 years of diagnosis.

The approval was supported by positive results from a prespecified interim analysis of the phase 3 I CAN trial. Ultomiris reduced proteinuria by 43.4% versus placebo at 34 weeks, with rapid reductions observed as early as week 10 and maintained through the interim analysis. Because the indication was granted under FDA's accelerated approval pathway based on proteinuria reduction, whether Ultomiris slows kidney function decline in patients with IgAN has not yet been established. Ongoing follow-up in the I CAN trial will evaluate changes in estimated glomerular filtration rate (eGFR) through 106 weeks and is intended to confirm clinical benefit.

Ultomiris is administered by intravenous infusion every 8 weeks following a loading dose. The safety profile was consistent with the drug's established experience in other approved indications, with no new safety concerns identified. The most common adverse events included upper respiratory tract infection, nasopharyngitis, and infusion-related reactions.

“This approval reflects the importance of continued innovation to help improve outcomes for people living with IgAN. With its approved use across several other rare diseases and established safety profile, Ultomiris provides a new treatment option in IgAN that gives patients and their physicians more choice as they navigate their care,” said Bonnie Schneider, Director & Co-Founder, IgA Nephropathy Foundation.

Sources: AstraZeneca. (2026 Oct 21). Ultomiris received accelerated approval in the US as first and only C5 complement inhibitor to reduce proteinuria in adults with primary immunoglobulin A nephropathy