FDA Approves Ultomiris to Treat IgA Nephropathy

The therapy is the first C5 complement inhibitor cleared to reduce proteinuria in adults with this kidney condition.

Updated on Oct. 27, 2026 in Allergies

Isometric editorial illustration of two matte, interlocking columns, representing the biological pathway targeted by new medical therapy. — The FDA has granted accelerated approval for the therapy Ultomiris to reduce proteinuria in adults living with primary immunoglobulin A nephropathy. AI Illustration. Upload story photo >

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The FDA has granted accelerated approval for Ultomiris to help reduce proteinuria in adults diagnosed with primary immunoglobulin A nephropathy. This medication works by inhibiting the C5 protein to prevent terminal complement-driven inflammation in the kidneys.

Why it matters

The approval addresses a critical need for patients with primary immunoglobulin A nephropathy, a condition that puts about half of those with elevated protein or reduced kidney function at high risk of progressing to kidney failure within a decade. The therapy aims to slow this damage by targeting the underlying biological pathways of the disease.

In a Phase 3 trial, Ultomiris achieved a 43.4% reduction in proteinuria compared to placebo at the 34-week mark. This data is based on an interim analysis of the ongoing I CAN trial, which plans to enroll 510 participants.

The players

FDA

The Food and Drug Administration is the federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human drugs and biological products.

Alexion

Headquartered in Boston, this company specializes in developing life-transforming therapies for patients with rare diseases and devastating conditions.

AstraZeneca

Based in Cambridge, this global biopharmaceutical firm focuses on the discovery, development, and commercialization of prescription medicines.

The details

Administered intravenously every eight weeks following an initial loading dose, the drug is designed to prevent the body from attacking healthy cells. The treatment duration in the ongoing trial spans 106 weeks to monitor long-term kidney function.

Day 1: Loading dose of Ultomiris administered.
Week 10: Earliest observed reduction in proteinuria.
Week 34: Proteinuria reduction measured in trial.
21 October 2026: FDA approval announced.
23 October 2026: Results presented at Kidney Week 2026.

The Big Picture

The I CAN Phase III trial provides the clinical evidence necessary to secure regulatory approval for new renal therapies, extending the path established for other rare disease treatments. Continued approval for this indication remains contingent upon the verification of clinical benefits within this ongoing study.

Patients with primary immunoglobulin A nephropathy may now have a new treatment option to help reduce proteinuria and potentially slow kidney damage. Individuals should consult with their healthcare providers regarding the intravenous dosing schedule and potential suitability for this therapy.

The takeaway

This approval represents a new approach to managing a serious kidney condition by targeting the terminal complement cascade. Patients at high risk of kidney failure should discuss these developments with their nephrologist to understand how this therapy could fit into their long-term health plan.