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US FDA gives AstraZeneca's Ultomiris accelerated approval to reduce proteinuria in IgAN
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Fusion42 · 24 October 2026 · Fusion42 review
The US FDA granted accelerated approval to AstraZeneca's Ultomiris (ravulizumab) for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression, making it the first and only C5 complement inhibitor approved for this purpose in the US. The approval is based on interim trial results demonstrating significant proteinuria reduction, with ongoing trials to verify clinical benefits for kidney function.
This Wire brief sits within Fusion42's coverage of Biotech, and 3 sources have reported it between 22 Oct 2026 and 2 Nov 2026.
◆ ◆ The Wire takeaway
Your rare disease biotech has a new path to US market validation via accelerated approvals for complex kidney disorders. Diversify your portfolio into complement inhibitors now that Ultomiris has opened this niche.
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3 sources · first reported 22 Oct 2026 · latest 2 Nov 2026
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