FDA Grants Accelerated Approval to Ultomiris for Kidney Disease

The FDA has granted accelerated approval to Ultomiris (ravulizumab) to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of disease progression, making it the first C5 complement inhibitor approved for this use. The approval, following Priority Review, relied on a prespecified interim analysis of the phase 3 I CAN trial showing a 43.4% reduction in proteinuria versus placebo at 34 weeks. Ultomiris is given intravenously every eight weeks based on body weight after a loading dose, with no new safety concerns identified. Continued approval depends on verifying clinical benefit in the ongoing trial, which will assess kidney function decline through week 106 to support full FDA approval.

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