FDA Grants Accelerated Approval for Ultomiris to Treat IgA Nephropathy

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Ultomiris (ravulizumab), developed by AstraZeneca's Alexion. This makes Ultomiris the first and only C5 complement inhibitor approved to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who face a risk of disease progression. This approval offers a new treatment option for patients with this rare kidney disease.