FDA Grants Priority Review to Ultomiris Supplemental Application for Rare Kidney Disorder
The U.S. Food and Drug Administration has accepted a supplemental Biologics License Application for Ultomiris (ravulizumab) from Alexion, part of AstraZeneca Rare Disease, and assigned Priority Review for treatment of adults with immunoglobulin A nephropathy (IgAN). The FDA’s Prescription Drug User Fee Act target action date is in the fourth quarte…