The FDA has granted accelerated approval to Ultomiris (ravulizumab-cwvz) for reducing proteinuria in adults with primary IgA nephropathy at risk of disease progression. In the phase 3 I CAN trial, the drug showed a 43.4% reduction in proteinuria compared to placebo at 34 weeks — with benefits appearing as early as week 10. It's the first C5 complement inhibitor approved for this progressive kidney disease.
The FDA has granted accelerated approval to Ultomiris (ravulizumab-cwvz), a C5 complement inhibitor developed by Alexion Pharmaceuticals/AstraZeneca, for reducing proteinuria in adults with primary IgA nephropathy (IgAN) who are at risk for disease progression. The approval is based on interim data from the ongoing phase 3 I CAN trial, marking a meaningful step forward for patients with this progressive kidney disease.
In the trial, Ultomiris demonstrated a 43.4% reduction in proteinuria compared to placebo at 34 weeks, with benefits emerging as early as week 10. Results were consistent across patient subgroups, suggesting broad applicability. Experts highlight that the drug targets terminal complement inhibition — a central driver of kidney inflammation — offering a mechanistically distinct approach to managing IgAN.
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Why it matters: This accelerated approval gives physicians a new therapeutic tool for IgAN, a disease with limited treatment options. However, traditional approval will hinge on the trial's primary endpoint — change in eGFR at week 106 — meaning the drug's ability to slow kidney function decline still needs to be confirmed.
