AstraZeneca's Ultomiris gains US accelerated approval to reduce proteinuria in adults with IgAN
AZN•Ultomiris received accelerated US approval to reduce proteinuria in adults with primary IgA nephropathy at risk of progression. Interim Phase III results showed a 43.4% reduction versus placebo at 34 weeks.
1. Approval and trial results
AstraZeneca's Ultomiris received accelerated US approval to reduce proteinuria in adults with primary IgA nephropathy at risk of progression. Interim Phase III results showed a 43.4% reduction in proteinuria versus placebo at 34 weeks. Continued approval may depend on confirmation of clinical benefit; whether the drug slows kidney function decline remains unestablished.
