FDA grants accelerated approval to Ultomiris for IgA nephropathy

AstraZeneca disclosed on 22 October 2026 that the FDA has granted accelerated approval to Ultomiris (ravulizumab) for adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression, describing it as the first and only C5 complement inhibitor cleared to reduce proteinuria in this population¹.

The approval rests on proteinuria reduction data, and the company noted that the accelerated approval is based on proteinuria reduction alone, and whether Ultomiris slows the decline of kidney function in IgAN patients has not yet been demonstrated¹. Continued approval may depend on verifying clinical benefit in the ongoing Phase III I CAN trial, which is tracking change in estimated glomerular filtration rate (eGFR) at week 106 as its endpoint for full approval¹.

The clearance followed FDA Priority Review based on a prespecified interim analysis of the I CAN trial. Ultomiris produced a 46.6% reduction in 24-hour urine protein creatinine ratio from baseline (95% CI: 39.0%-53.2%) at week 34, versus 5.6% for placebo (95% CI: -4.9%-15.0%), for a placebo-adjusted effect of 43.4% (95% CI: 33.5%-51.8%; p<0.0001)¹. The effect appeared as early as week 10, with a 36.7% reduction versus 8.5% for placebo¹.

The most common adverse events were upper respiratory tract infection (11.3%), nasopharyngitis (9.2%) and infusion-related reactions (8.4%) in the Ultomiris arm, versus upper respiratory tract infection (10.2%), nasopharyngitis (9.0%) and hypertension (6.6%) with placebo¹.

Ultomiris is dosed intravenously every eight weeks in adults following a loading dose¹. The company said this marks the fifth approved indication for Ultomiris¹. Late-breaking data from the trial were set for presentation at the American Society of Nephrology's Kidney Week on 23 October 2026¹, and regulatory submissions based on the interim results remain under review in Japan and other countries¹.