FDA approves Ultomiris for proteinuria in primary IgA nephropathy

The FDA approved Ultomiris to reduce proteinuria in adults with primary immunoglobulin A nephropathy who are at risk for disease progression, Healio reported, citing a company press release. The accelerated approval was based on a prespecified interim analysis of phase 3 I CAN study data. Ultomiris, or ravulizumab-cwvz, is a C5 complement inhibitor.

At 34 weeks, the study showed a 43.4% reduction in proteinuria compared with placebo, according to the release. The reduction was seen as early as week 10, when it was 36.7% compared with placebo, and was sustained through 34 weeks. The placebo group had an 8.5% reduction at 34 weeks. The I CAN trial will continue to assess change from baseline in eGFR at week 106. The release said it has not been established whether Ultomiris slows kidney function decline, and continued approval may depend on confirming clinical benefit in the ongoing trial.