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FDA grants accelerated approval for Ultomiris in IgAN, showing 43.4% proteinuria reduction
AZNAstrazeneca PLC
The US Food and Drug Administration has granted accelerated approval to AstraZeneca’s Ultomiris (ravulizumab) as the first and only C5 complement inhibitor for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). The decision follows a Priority Review based on prespecified interim results from the Phase III I CAN trial, which demonstrated a 43.4% reduction in proteinuria versus placebo at week 34. Continued approval is contingent upon verification of clinical benefit regarding kidney function decline in the ongoing trial. AstraZeneca PLC operates as a global biopharmaceutical company focused on oncology, rare disease, and biotherapeutics.