FDA grants accelerated approval to AstraZeneca Ultomiris for primary IgA nephropathy in adults
The FDA has granted accelerated approval to AstraZeneca's Ultomiris for adults with primary IgA nephropathy, introducing a C5 complement inhibitor treatment to reduce proteinuria.
Ultomiris (ravulizumab-cwvz) targets complement component C5 and has received accelerated approval in the United States to reduce proteinuria in adults with primary immunoglobulin A nephropathy, a rare kidney disease.
The decision was supported by the Phase III I CAN programme, which previously reported a 43.4% reduction in proteinuria versus placebo at 34 weeks in a prespecified interim analysis, while the exact label eligibility criteria and confirmatory requirements should be checked against FDA prescribing information.
Field | Content |
Article Type | Approvals |
Regulatory Authority | U.S. Food and Drug Administration |
Regulatory Decision | Accelerated approval |
Company | AstraZeneca |
Drug Name | Ultomiris |
Generic Name | Ravulizumab-cwvz |
Therapeutic Area | Nephrology; rare kidney diseases |
Indication | Reduction of proteinuria in adults with primary immunoglobulin A nephropathy |
Patient Population | Adults with primary IgA nephropathy; additional label eligibility criteria not confirmed in supplied summary |
Drug Class | Complement inhibitor |
Mechanism of Action | Inhibition of complement component C5 |
Supporting Clinical Study | Phase III I CAN |
Reported Clinical Result | 43.4% reduction in proteinuria versus placebo at 34 weeks in a prespecified interim analysis |
Clinical Endpoint | Proteinuria reduction |
Approval Pathway | Accelerated approval |
Confirmatory Requirements | Not specified in supplied summary; consult final FDA prescribing information |
Geography | United States |
Announcement Date | 21 October 2026 |
What Happened | The FDA granted accelerated approval to Ultomiris to reduce proteinuria in adults with primary IgA nephropathy. |
Why It Matters | The decision introduces a complement C5-targeting treatment approach for a rare kidney disease associated with progressive kidney damage. |
Clinical Evidence | The Phase III I CAN programme reported a 43.4% reduction in proteinuria versus placebo at 34 weeks in an interim analysis. |
Key Takeaway | Ultomiris offers a newly authorised complement-inhibition option for reducing proteinuria in primary IgA nephropathy; accelerated approval does not establish confirmed long-term kidney protection. |
What to Watch | Final prescribing information, confirmatory clinical evidence, long-term kidney outcomes, reimbursement and treatment adoption. |
Primary Source | AstraZeneca |
Primary Source URL | https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/ULTOMIRIS-ravulizumab-cwvz-received-accelerated-approval-in-the-US-as-first-and-only-C5-complement-inhibitor-to-reduce-proteinuria-in-adults-with-primary-immunoglobulin-A-nephropathy.html |
Relevant Date | 21 October 2026 |
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