AstraZeneca’s Ultomiris (Ravulizumab) Receives the US FDA’s Accelerated Approval to Reduce Proteinuria in Adults with IgA Nephropathy (IgAN)

Shots: Alexion, AstraZeneca Rare Disease has received the US FDA’s accelerated approval for Ultomiris (ravulizumab) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression, following Priority Review; it is the 1st & only C5 complement inhibitor approved for this use & marks the 5th indication for Ultomiris Approval was based on a prespecified interim analysis of the P-III (I CAN) trial evaluating Ultomiris vs PBO (1:1; IV for 106wks) in adults with IgAN on stable SoC, where Ultomiris showed a 46.6% vs 5.6% reduction in 24-hr UPCR from baseline at Wk 34 (PBO-adjusted effect: 43.4%; p<0.0001), with reductions seen as early as Wk 10 (36.7% vs 8.5%) Continued approval may be contingent on the I CAN trial’s 1EP of eGFR change from baseline at Wk 106, intended to support traditional approval; late-breaking data will be presented at ASN Kidney Week on Oct 23, 2026, while regulatory submissions are under review in Japan & other countries Ref: AstraZeneca  |   Image: AstraZeneca  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post AstraZeneca’s Ultomiris (Ravulizumab) Receives the US FDA’s Accelerated Approval to Reduce Proteinuria in Adults with IgA Nephropathy (IgAN) appeared first on PharmaShots.