On June 15 local time, AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the supplemental Biologics License Application (sBLA) submitted by its rare disease unit, Alexion, for Ultomiris (ravulizumab) for the treatment of adults with immunoglobulin A nephropathy (IgAN). The Prescription Drug User Fee Act (PDUFA) decision date is expected in the fourth quarter of 2026.
The sBLA is based on pre-specified interim analysis results from the I CAN Phase III trial, which were recently presented at the 2026 European Renal Association (ERA) Congress. I CAN is a global Phase III, randomized, double-blind, placebo-controlled trial evaluating Ultomiris in adults with IgAN at risk of disease progression. Participants were on stable standard-of-care IgAN concomitant therapy for at least three months prior to screening.
In the trial, Ultomiris achieved a 46.6% reduction from baseline in 24-hour urine protein-to-creatinine ratio (UPCR) at Week 34 (95% CI: 39.0%, 53.2%), compared to 5.6% in the placebo group (95% CI: -4.9%, 15.0%), resulting in a placebo-adjusted treatment effect of 43.4% (95% CI: 33.5%, 51.8%; p<0.0001).
Rapid reduction in proteinuria was observed with Ultomiris as early as Week 10 (36.7% [95% CI: 30.2%, 42.6%]) and was sustained through 34 weeks, compared to placebo (8.5% [95% CI: 0.5%, 15.8%]). The results were consistent across patient subgroups, reflecting diverse demographic and baseline clinical characteristics and disease severity.
The trial’s primary endpoint of change from baseline in estimated glomerular filtration rate (eGFR) will be measured at Week 106.
The safety profile observed in the I CAN trial was consistent with the known profile of Ultomiris and generally well tolerated, with no new safety concerns identified. The most common adverse events were upper respiratory tract infection, nasopharyngitis, and infusion-related reactions.
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