Ultomiris (ravulizumab) for IgA nephropathy
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The FDA is expected to decide on Ultomiris for IgA nephropathy in Q4 2026, under a sBLA from AstraZeneca (Alexion).
What is being decided
AstraZeneca (Alexion) has a sBLA under FDA review for Ultomiris (ravulizumab) in IgA nephropathy. Priority review; AstraZeneca has disclosed a Q4 window but no exact date.
Who this 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). Six 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 Trutakna (atacicept) in July 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.
About the drug
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.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
Where IgA Nephropathy treatment stands today
Read our full IgA Nephropathy treatment summary
IgA nephropathy treatment has transformed dramatically, with six 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 inhibitor Fabhalta (iptacopan), the APRIL inhibitor Voyxact (sibeprenlimab), and, newest, Trutakna (atacicept), approved in July 2026 as the first FDA-approved dual BAFF/APRIL inhibitor. 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 and Ultomiris (ravulizumab) are under FDA review, with decisions expected by the end of 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, 90 IgA Nephropathy trials are recruiting
Whatever the FDA decides here, research on IgA Nephropathy does not stop. A few currently enrolling studies, US sites first:
Earlier-stage drugs Trial Friend tracks for IgA Nephropathy
We'll email you when the decision is public, with what it means in plain language, and when new trials open for IgA Nephropathy. Unsubscribe anytime.
Our coverage
Frequently asked questions
When will the FDA decide on Ultomiris?
AstraZeneca (Alexion) expects a decision in Q4 2026 but has not given an exact date.
Who disclosed it: AstraZeneca (Alexion). The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: AstraZeneca press release
What is Ultomiris being reviewed for?
AstraZeneca (Alexion) submitted a sBLA for Ultomiris in IgA nephropathy.
What to know: Priority review; AstraZeneca has disclosed a Q4 window but no exact date.
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 6 FDA-approved drugs for IgA Nephropathy.
Approved: Tarpeyo (budesonide), Filspari (sparsentan), Fabhalta (iptacopan), Vanrafia (atrasentan), Voyxact (sibeprenlimab), Trutakna (atacicept).
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 that enrolled 584 adults. In April 2026, AstraZeneca announced the trial met its first primary endpoint, a reduction in proteinuria (UPCR) at week 34, and said it would seek accelerated approval.
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 lists the warnings in full.
Can I get Ultomiris before the FDA decides?
Ultomiris is already FDA approved for other conditions, but not yet for IgA nephropathy, and insurers may not cover use for an unapproved condition.
Trials: 90 IgA Nephropathy trials are recruiting now. See them.
Check your fit: Match Me compares your details with every open trial.
Expanded access: your doctor can ask AstraZeneca (Alexion) directly. Registered programs are listed on ClinicalTrials.gov.
How much will Ultomiris cost?
Ultomiris is already sold in the US for other conditions. Trial Friend does not list a price, and coverage for IgA nephropathy depends on the FDA decision and your insurer.
Drugmaker help: Alexion OneSource.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Ultomiris decision?
This page updates with the outcome the day it is announced.
If approved: 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.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from AstraZeneca press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.