FDA Grants Accelerated Approval to Ultomiris for IgA Nephropathy

The Food and Drug Administration (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. This approval was supported by data from the Phase 3 I CAN trial.