AstraZeneca's Ultomiris gains FDA accelerated approval for IgA nephropathy in adults

AstraZeneca said the U.S. Food and Drug Administration granted accelerated approval for Ultomiris in adults with immunoglobulin A nephropathy, a rare kidney disease that can lead to renal failure. Reuters reported the approval on October 21, 2026.

Ultomiris Data Behind The FDA Decision

AstraZeneca said Ultomiris reduced proteinuria, excess protein in the urine, by 43.4% compared with placebo after 34 weeks in an interim analysis of the late-stage trial. The drugmaker said the FDA granted the approval under its accelerated pathway, and that the ongoing trial will continue through 106 weeks to determine whether Ultomiris slows loss of kidney function to support traditional approval.

The company also said the drug was the first and only approved C5 inhibitor for the disease, targeting an immune-system pathway linked to kidney inflammation. AstraZeneca said more than 200,000 people in the United States have the condition, and about half of those with elevated urine protein levels or reduced kidney function are at high risk of kidney failure within 10 years. The company said no new safety concerns were identified in the study and applications are also under review in Japan and other countries.

AstraZeneca's Rare Disease Business At A Glance

AstraZeneca is a global pharmaceutical company that develops and markets oncology, cardiometabolic, rare disease, and respiratory prescription medicines, according to akta.pro company records. The same records list full year revenue of $60.4 billion with a 17.2% net margin, and Q1 2026 revenue of $12.68 billion, up 19% with 26% oncology sales growth. Management guidance puts annual sales at $80 billion by 2030, with 20 planned drug launches.

Earlier Approvals And Partnerships This Month

AstraZeneca's Breztri Aerosphere received US approval for COPD and asthma via a supplemental new drug application, In Vivo reported in October 2026. On October 20, 2026, Oracle and AstraZeneca announced a non-binding agreement to explore AI and real-world data for identifying clinical trial patients and accelerating medical evidence, Jiemian reported. The European Medicines Agency's CHMP issued eight October decisions, including AstraZeneca's withdrawal of a prostate cancer filing, European Biotechnology Magazine reported on October 19, 2026.

What Comes Next For Ultomiris

The ongoing trial will continue through 106 weeks to assess whether Ultomiris slows loss of kidney function, data intended to support traditional approval. Applications for the treatment are also under review in Japan and other countries.