AstraZeneca’s Ultomiris Cuts Proteinuria in Phase III IgAN Trial, Seeks Accelerated Approval
AstraZeneca’s Ultomiris met its primary endpoint in the Phase III I CAN trial for immunoglobulin A nephropathy, cutting 24-hour urine protein-creatinine ratio by a statistically significant margin at week 34, with reductions evident from week 10. Safety data aligned with previous profiles and AstraZeneca will seek accelerated approval.
1. Trial Design and Results
The Phase III I CAN trial enrolled patients with immunoglobulin A nephropathy and measured 24-hour urine protein-creatinine ratio (UPCR) through week 34. Ultomiris achieved a statistically significant reduction in UPCR at week 34, with initial reductions observed as early as week 10.
2. Safety Profile
Ultomiris exhibited a safety profile consistent with prior studies and showed no new adverse events in IgAN patients, reinforcing its established tolerability in rare complement-mediated disorders.
3. Regulatory Filings and Next Steps
AstraZeneca plans to submit these data for accelerated approval in key global markets while awaiting final analyses of the trial’s second primary endpoint—kidney filtration rate—at week 106.