AstraZeneca to seek accelerated approval of Ultomirisin in IgAN on Phase III data
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By Abigail Beaney
Published on April 22, 2026.
AstraZeneca plans to seek accelerated approval of Ultomirisin in IgAN, a rare, inflammatory disease of the kidneys, following a Phase III study showing a significant reduction in proteinuria after 34 weeks. The drug met its first primary endpoint of change from baseline in estimated glomerular filtration rate (eGFR), which will be measured at week 106. Secondary endpoints such as albuminuria, partial remission, and change in Functional Assessment of Chronic Illness Therapy (FACIT) are not yet available. The ongoing study by AstraZeneca's rare disease company Alexion will enrol 510 patients with IgAN. The safety profile of the trial was found to be consistent with the known profile of Ultmiris.
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