Regulatory review begins for ravulizumab as a potential treatment for adults with immunoglobulin A nephropathy.
The US Food and Drug Administration (FDA) has accepted and granted Priority Review to a supplemental Biologics License Application (sBLA) for ravulizumab as a potential treatment for adults with immunoglobulin A nephropathy (IgAN).
The application is supported by results from a prespecified interim analysis of the phase 3 I CAN trial, which was presented at the 2026 European Renal Association (ERA) congress. If approved, ravulizumab would become the first C5 complement inhibitor available in the US for IgAN. The Prescription Drug User Fee Act (PDUFA) action date for the FDA’s decision is expected in the fourth quarter of 2026.
Phase 3 I CAN trial
The I CAN trial (NCT06291376) is a global, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of ravulizumab in adults with IgAN at risk of disease progression.
In a prespecified interim analysis, ravulizumab reduced 24-hour urine protein creatinine ratio (UPCR) from baseline by 46.6% (95% CI: 39.0%, 53.2%) at Week 34, compared with 5.6% (95% CI: -4.9%, 15.0%) for placebo. The placebo-adjusted treatment effect was 43.4% (95% CI: 33.5%, 51.8%; p<0.0001).
In the ravulizumab-treated group, early reductions in proteinuria was observed from Week 10 (36.7% [95% CI: 30.2%, 42.6%]) and maintained through Week 34, versus placebo (8.5% [95% CI: 0.5%, 15.8%]). Results were consistent across patient subgroups, and the safety profile was consistent with the known profile of ravulizumab.
The trial’s primary endpoint assessing change in estimated glomerular filtration rate (eGFR) will be evaluated at Week 106.
About immunoglobulin A nephropathy
IgAN is a rare inflammatory kidney disease caused by the accumulation of abnormal immunoglobulin A (IgA) immune complexes in the kidneys. These deposits can activate the complement system, leading to inflammation and damage of the kidneys, including the glomeruli, which is responsible for filtering the blood. Over time, kidney damage can progress to chronic kidney disease and, in some patients, end-stage kidney disease.
Symptoms may include blood in the urine, proteinuria, edema and high blood pressure. However, many people do not experience noticeable symptoms in the early stages, meaning diagnosis may occur after kidney damage has already occurred.
About ravulizumab
Ravulizumab is a long-acting C5 complement inhibitor that targets the terminal complement pathway, which can contribute to inflammatory processes when dysregulated in certain diseases.
Ravulizumab is currently approved in multiple countries, including the US, for several conditions, including paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS), generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD).
Reference
Astrazeneca. Ultomiris granted Priority Review in the US as treatment for adults with immunoglobulin A nephropathy. 2026. Press release. Available at: www.astrazeneca.com/media-centre/press-releases/2026/ultomiris-granted-priority-review-in-the-us-as-treatment-for-adults-with-immunoglobulin-a-nephropathy.html (accessed July 08 2026).
This content has been developed independently by Touch Medical Media for touchIMMUNOLOGY. This article was created by the touchIMMUNOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) No funding was received in the publication of this article.
Cite: FDA grants Priority Review to ravulizumab for immunoglobulin A nephropathy. touchIMMUNOLOGY. July 8 2026.
Editor: Victoria Smith, Senior Content Editor.
