FDA approves Ultomiris to reduce proteinuria for primary IgAN
The FDA has approved Ultomiris to reduce proteinuria in adult patients with primary immunoglobulin A nephropathy who are at risk for disease progression, according to a company press release.
The indication was granted as an accelerated approval based on the reduction of proteinuria demonstrated during a prespecified interim analysis of phase 3 I CAN study data.
According to the release, ravulizumab-cwvz (Ultomiris, Alexion Pharmaceuticals/AstraZeneca), a C5 complement inhibitor, showed 43.4% reduction in proteinuria at 34 weeks compared with patients taking placebo. The reduction was seen as