Ultomiris Secures Priority Review Status in the US for Adult IgA Nephropathy
Alexion, AstraZeneca Rare Disease announced that the FDA has accepted and granted Priority Review to the supplemental Biologics License Application (sBLA) for Ultomiris as a potential treatment for adults with Immunoglobulin A Nephropathy. The FDA reserves Priority Review for therapies that may provide meaningful advances in safety, efficacy, or patient care compared with existing treatment options. A regulatory decision is expected in Q4 2026 under the Prescription Drug User Fee Act (PDUFA) timeline.
IgAN is a rare kidney disorder characterized by the accumulation of abnormal IgA-conta...
