Shots:
- The US FDA has accepted sBLA & granted priority review to AZ‘s Ultomiris (ravulizumab) for the treatment of adults with immunoglobulin A nephropathy (IgAN), with a PDUFA action date anticipated in Q4’26
- sBLA was supported by the interim analysis data from the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with IgAN who are at risk of disease progression
- Trial showed a 46.6% reduction in 24-hr. UPCR at 34wks. vs 5.6%, as early as Wk. 10 & sustained through 34wks., while the 1EP of change in eGFR will be measured at Wk. 106.; results were consistent across all subgroups. Data were presented at ERA’26
Ref: AstraZeneca | Image: AstraZeneca | Press Release
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