FDA Grants Accelerated Approval for Ultomiris in Primary IgA Nephropathy

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Ultomiris (ravulizumab) for adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. This marks the first and only C5 complement inhibitor approved to reduce proteinuria in this patient population. The approval was based on positive Phase III trial results, which demonstrated a 43.4% reduction in proteinuria compared to placebo.