ASTRAZENECA PLC (AZN) Form 6-K — Oct 22, 2026
AstraZeneca's Alexion rare-disease unit received US FDA accelerated approval for Ultomiris (ravulizumab) to reduce proteinuria in adults with primary IgA nephropathy (IgAN), making it the first and only C5 complement inhibitor approved for this use. The approval was based on a prespecified interim analysis of the Phase III I CAN trial, in which Ultomiris showed a 43.4% placebo-adjusted reduction in proteinuria at 34 weeks (p<0.0001), with effects visible as early as week 10 and no new safety concerns identified. IgAN affects more than 200,000 people in the US, roughly half of whom with elevated proteinuria or reduced kidney function risk progressing to kidney failure within 10 years.
Key figures
- Trial weeks
- 34
- Us igan patients
- more than 200,000
- Indications count
- 5
- Placebo upcr reduction
- 5.6%
- Upcr reduction from baseline
- 46.6%
- Proteinuria reduction vs placebo
- 43.4%
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