22nd Oct 2026 09:45
AstraZeneca PLC - Cambridge, England-based pharmaceutical company - Says its Ultomiris drug has received accelerated approval from the US Food & Drug Administration to reduce proteinuria, or excess protein in urine, in adults with primary immunoglobulin A nephropathy, a rare inflammatory kidney disease, who are at risk of disease progression. Ultomiris becomes the first and only C5 complement inhibitor approved in the US for this indication. Approval follows interim results from the phase III I CAN trial, which showed a 43.4% reduction in proteinuria compared with placebo after 34 weeks. AstraZeneca says the trial remains ongoing to assess whether Ultomiris can slow kidney function decline, with continued approval potentially dependent on confirmation of clinical benefit. The approval marks the fifth indication for Ultomiris.
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By Eva Castanedo, Alliance News senior economics reporter
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