Marc Dunoyer

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FDA approves Ultomiris for IgA nephropathy

Leading Alexion as Ultomiris wins its fifth US indication

The US Food and Drug Administration cleared AstraZeneca's Ultomiris on 21 October to reduce proteinuria, excess protein in the urine, in adults with primary immunoglobulin A nephropathy (IgAN). The approval is accelerated, so AstraZeneca must still show the drug preserves kidney function or risk losing the indication.

Updated Oct 23

Notable Quotes

"This approval marks the fifth indication for Ultomiris, building on Alexion's pioneering leadership across multiple complement-mediated rare diseases."

from FDA approves Ultomiris for IgA nephropathy · Updated Oct 23

"Many patients continue to face the risk of progression to kidney failure, underscoring the need for more targeted therapies that can slow the course of disease."

from FDA approves Ultomiris for IgA nephropathy · Updated Oct 23