Ultomiris (ravulizumab) for IgA nephropathy

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, up to 40% progress to end-stage kidney disease within 20 years of diagnosis. Six disease-specific therapies targeting complement, endothelin, and the APRIL/BAFF pathway have reached FDA approval since 2021, most recently Trutakna (atacicept) in July 2026.

Prevalence: Incidence is about 1 in 100,000 people per year in the U.S. (IgA Nephropathy Foundation); cumulative U.S. prevalence is estimated at roughly 130,000 to 150,000 cases. 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

IgA nephropathy treatment has transformed dramatically, with six disease-specific FDA-approved therapies now available: targeted-release budesonide (Tarpeyo), the endothelin/angiotensin blockers Filspari (sparsentan) and Vanrafia (atrasentan), the complement inhibitor Fabhalta (iptacopan), the APRIL inhibitor Voyxact (sibeprenlimab), and — newest, approved in July 2026 — Trutakna (atacicept), the first 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, plus late-stage programs like felzartamab, zigakibart, povetacicept, and sefaxersen. 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.

Meanwhile, 96 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:

Other drugs Trial Friend tracks for IgA Nephropathy

Our coverage

Frequently asked questions

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 weekly.