What the FDA decided on Ultomiris for IgA nephropathy
The FDA approved Ultomiris (ravulizumab) for IgA nephropathy.
The FDA granted accelerated approval on October 21, 2026, to reduce proteinuria (protein in the urine) in adults with primary IgA nephropathy at risk of disease progression. AstraZeneca calls it the first and only C5 inhibitor approved for the disease. In the Phase 3 I CAN trial, urine protein fell 46.6% from baseline at week 34 against 5.6% on placebo, a 43.4% placebo-adjusted reduction.
AstraZeneca says it has not been established whether Ultomiris slows kidney function decline. The same trial is still measuring kidney function (eGFR) through week 106, and continued approval may depend on those results. Adults weighing 40kg or more get a weight-based loading dose, then IV infusions starting 2 weeks later and every 8 weeks after that.
The boxed warning for serious meningococcal infections and the REMS program carry over from its other uses. The FDA posted the updated label with the approval on Drugs@FDA.
Who the Ultomiris decision matters to
IgA nephropathy is the most common primary glomerulonephritis worldwide, caused by abnormal IgA1 antibodies depositing in the kidney's mesangium, activating complement pathways and triggering inflammation that progressively damages the kidneys. While some patients have a benign course, about 1 in 5 people with IgA nephropathy develop kidney failure within 10 years (NIDDK).
Seven disease-specific therapies, including a gut-targeted steroid and drugs targeting complement, endothelin, and the APRIL/BAFF pathway have reached FDA approval since 2021, most recently Ultomiris (ravulizumab), whose accelerated approval AstraZeneca announced on October 21, 2026.
Prevalence: About 2 new cases per 100,000 people each year in the U.S., and an estimated 199,000 to 208,000 Americans were living with IgA nephropathy in 2021 (Otsuka-funded study, Clinical Nephrology, 2025). About 1 in 10 kidney biopsies in the U.S. show IgA nephropathy (NIDDK). Significantly more common in East Asian and Pacific Islander populations, with reported incidence up to 4 times higher. See our full IgA Nephropathy page for current treatments, recruiting trials, and community resources.
How Ultomiris works
Ultomiris: long-acting humanized monoclonal antibody that inhibits complement C5, providing sustained terminal complement pathway blockade. Our full Ultomiris profile covers how it works, side effects in plain language, and its trial history.
Where IgA Nephropathy treatment stands today
Read our full IgA Nephropathy treatment summary
IgA nephropathy treatment has transformed dramatically, with 7 disease-specific FDA-approved therapies now available: targeted-release budesonide (Tarpeyo), the endothelin blockers Filspari (sparsentan, which also blocks angiotensin) and Vanrafia (atrasentan), the complement inhibitors Fabhalta (iptacopan) and Ultomiris (ravulizumab), the APRIL inhibitor Voyxact (sibeprenlimab), and Trutakna (atacicept), approved in July 2026 as the first FDA-approved dual BAFF/APRIL inhibitor. Ultomiris is the newest, with accelerated approval announced by AstraZeneca on October 21, 2026.
Beyond the approved options, active trials include Biohaven's BHV-1400, a first-in-class degrader that selectively removes the pathogenic Gd-IgA1 antibody and whose pivotal trial is expected to start in the second half of 2026, plus late-stage programs like felzartamab, zigakibart and sefaxersen. Povetacicept is under FDA review, with a decision due November 30, 2026.
These targeted options represent a genuine shift from generic immunosuppression toward addressing the specific mechanisms of kidney damage. The IgA Nephropathy Foundation and NephCure maintain current trial databases.
If you have persistent protein in your urine above 0.5-1 gram per day despite maximum supportive therapy, you may qualify for trials of emerging therapies, and with multiple approved drugs now available, discussing the full treatment sequence with your nephrologist matters more than ever. A kidney biopsy is essential for diagnosis and helps predict your individual risk of progression.
The IgA Nephropathy page has every treatment and trial →Meanwhile, 93 IgA Nephropathy studies are open or about to open
The FDA's decision does not end research on IgA Nephropathy. The most recently updated:
Earlier-stage drugs Trial Friend tracks for IgA Nephropathy
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Frequently asked questions
Has the FDA decided on Ultomiris?
The FDA has already decided. It approved the application.
Details: the outcome and what it means are at the top of this page.
Source: AstraZeneca press release
What was Ultomiris approved for?
The FDA approved AstraZeneca (Alexion)'s sBLA for Ultomiris in IgA nephropathy.
What to know: The FDA granted accelerated approval on October 21, 2026, to reduce proteinuria (protein in the urine) in adults with primary IgA nephropathy at risk of disease progression. AstraZeneca calls it the first and only C5 inhibitor approved for the disease. In the Phase 3 I CAN trial, urine protein fell 46.6% from baseline at week 34 against 5.6% on placebo, a 43.4% placebo-adjusted reduction. AstraZeneca says it has not been established whether Ultomiris slows kidney function decline. The same trial is still measuring kidney function (eGFR) through week 106, and continued approval may depend on those results. Adults weighing 40kg or more get a weight-based loading dose, then IV infusions starting 2 weeks later and every 8 weeks after that. The boxed warning for serious meningococcal infections and the REMS program carry over from its other uses. The FDA posted the updated label with the approval on Drugs@FDA.
How it works: Long-acting humanized monoclonal antibody that inhibits complement C5, providing sustained terminal complement pathway blockade.
More: the Ultomiris drug page explains it in plain language.
Is there already an FDA-approved treatment for IgA Nephropathy?
Yes. Trial Friend's drug list includes 7 FDA-approved drugs for IgA Nephropathy.
Approved: Tarpeyo (budesonide), Filspari (sparsentan), Fabhalta (iptacopan), Vanrafia (atrasentan), Voyxact (sibeprenlimab), Trutakna (atacicept), Ultomiris (ravulizumab).
Also coming: Felzartamab, Zigakibart, Povetacicept, Sefaxersen.
Check: the IgA Nephropathy page also searches FDA drug labels for approved treatments.
What did the Ultomiris trials show?
The Phase 3 I CAN trial (NCT06291376) is a double-blind, randomized, placebo-controlled study in 28 countries. ClinicalTrials.gov lists 584 adults enrolled, while the FDA label describes 485 patients in the study.
More: the Ultomiris drug page has the full trial history and sources.
What are the side effects of Ultomiris?
Ravulizumab is already approved for other conditions, so its safety profile is well-characterized. Ultomiris carries a boxed warning for serious meningococcal infections, which can become life-threatening or fatal if not caught early.
More: the Ultomiris drug page has the label's warnings in full.
How much will Ultomiris cost?
Trial Friend does not list a price for Ultomiris. What you pay depends on your insurance and on help from the drugmaker or a charity fund.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Ultomiris decision?
The FDA approved Ultomiris for IgA nephropathy on October 21, 2026.
Next steps: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
Where this outcome comes from
The outcome on this page comes from AstraZeneca press release. This page rechecks against our calendar, which is re-verified daily.