$AZN · ASTRAZENECA PLC
AstraZeneca announced FDA accelerated approval of Ultomiris (ravulizumab) for reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. The approval is based on a prespecified interim analysis of the Phase III I CAN trial showing a 43.4% placebo-adjusted reduction in proteinuria at 34 weeks (p<0.0001). Continued approval is contingent on verification of clinical benefit via the eGFR primary endpoint at week 106. Ultomiris is the first C5 complement inhibitor approved for IgAN, which affects over 200,000 people in the US.
- Ultomiris showed a 43.4% placebo-adjusted reduction in proteinuria at 34 weeks (p<0.0001) in the Phase III I CAN trial.
- The approval is accelerated, with continued approval contingent on eGFR data at week 106 from the ongoing I CAN trial.
- Ultomiris is the first and only C5 complement inhibitor approved for IgAN, a disease affecting over 200,000 people in the US.
- This is Ultomiris's fifth approved indication, expanding Alexion's rare-disease franchise beyond PNH, aHUS, gMG, and NMOSD.
- Regulatory submissions are also under review in Japan and additional countries based on the same interim results.
Extended-hours trading shows AZN at $170.07, up 0.96% from the regular close of $168.45, indicating a modestly positive initial reaction to the Ultomiris label expansion. The $261B market cap limits the single-product impact on the stock.
Ultomiris becomes the first C5 complement inhibitor in a 200,000+ US patient IgAN market, marking the drug's fifth approved indication and expanding Alexion's rare-disease portfolio into a new high-ne
Ultomiris competes in the growing IgAN market alongside Calliditas's Tarpeyo (now fully approved) and Novartis's Fabhalta (iptacopan), which received FDA approval for IgAN in 2025. The C5 inhibition mechanism differentiates Ultomiris from these alternatives.
Accelerated approval is contingent on verification of clinical benefit in the ongoing I CAN trial; failure to demonstrate slowed kidney function decline (eGFR endpoint at week 106) could result in withdrawal. The safety profile, while consistent with prior Ultomiris use, showed infusion-relatedreac
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