AstraZeneca's Ultomiris Receives Accelerated FDA Approval for IgA Nephropathy

Alexion, AstraZeneca Rare Disease's Ultomiris (ravulizumab) has been granted accelerated approval by the FDA to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. The approval is based on positive results from a Phase III trial, showing a 43.4% reduction in proteinuria versus placebo at 34 weeks. Continued approval is contingent on verification of clinical benefit in the ongoing Phase III trial.