FDA Accelerated Approval: Ravulizumab (Ultomiris) for IgA Nephropathy | I CAN Trial

In October 2026, the US FDA granted accelerated approval to ravulizumab (Ultomiris) to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk of disease progression. It is the first C5 complement inhibitor approved for this use. In this video: • The challenge of persistent proteinuria in IgAN despite optimised standard of care • Efficacy data from the phase 3 I CAN trial • Safety and REMS requirements • What is not yet proven • The open question of sequencing with RAS blockade, endothelin receptor antagonists and SGLT2 inhibitors Key facts • Indication: To reduce proteinuria in adults with primary IgAN at risk of disease progression • Approval type: Accelerated approval, based on proteinuria reduction • Trial: I CAN, a global, randomised, double-blind, placebo-controlled phase 3 trial, designed to enrol about 510 adults in 28 countries, all on stable standard-of-care treatment for at least 3 months • Week 34 result (prespecified interim analysis): 24-hour UPCR fell 46.6% with ravulizumab vs 5.6% with placebo; placebo-adjusted reduction 43.4% (95% CI 33.5–51.8%; p less than 0.0001) • Onset: Reduction seen as early as week 10 (36.7%) • Dosing: Weight-based IV infusion every 8 weeks after a loading dose • Most common adverse events: upper respiratory tract infection 11.3% (placebo 10.2%), nasopharyngitis 9.2% (placebo 9.0%), infusion-related reactions 8.4% • Boxed warning: Serious meningococcal infections. Meningococcal vaccination must be completed or updated at least 2 weeks before the first dose, unless the risk of delaying treatment outweighs the risk of infection. Available only through the ULTOMIRIS and SOLIRIS REMS program. Not yet established Whether ravulizumab slows decline in kidney function has not been established. The I CAN trial continues, with change in eGFR at week 106 as the primary endpoint of the final analysis. Continued approval may depend on these results. Sources: AstraZeneca press release (21 October 2026); I CAN interim analysis, ERA Congress 2026; ULTOMIRIS US prescribing information; ClinicalTrials.gov NCT06291376 For education only. Not medical advice. Treatment decisions should be made with a nephrologist. #IgANephropathy #Ravulizumab #Nephrology #KidneyHealth #Proteinuria