Overview
- The FDA granted accelerated approval to Ultomiris (ravulizumab) to reduce proteinuria in adults with primary IgA nephropathy, a decision announced by AstraZeneca in a company release on Oct. 21.
- A prespecified interim analysis of the Phase 3 I CAN trial showed a placebo‑adjusted 43.4% drop in urinary protein at 34 weeks with reductions visible by week 10.
- The approval is conditional on the ongoing I CAN trial completing its planned 106‑week analysis of change in estimated glomerular filtration rate, which the agency will use to judge whether to convert to traditional approval.
- The trial reported no new safety signals and uses intravenous, weight‑based dosing with a loading dose followed by maintenance infusions every eight weeks in adults.
- Ultomiris enters a crowded IgAN market that already includes approved therapies such as Tarpeyo and Fabhalta, and uptake will depend on confirmatory eGFR results, pricing, infusion logistics, and how patients and clinicians weigh benefits versus existing options.