FDA approves ravulizumab for IgA nephropathy

Phase 3 results showed reduced proteinuria at 34 weeks, but effects on kidney function remain unconfirmed.

By
Mouj Hijazi
October 22, 2026
3 min

MDSpire News

At a Glance

Category	Detail
Condition	Clinical topic addressed by the source article: FDA approves ravulizumab for IgA nephropathy
Key Mechanisms	Ravulizumab is a C5 complement inhibitor.
Target Population	Patients or participants described in the source article.
Care Setting	Care setting described in the source article.

Key Highlights

The FDA granted accelerated approval to ravulizumab-cwvz (Ultomiris) to reduce proteinuria in adults with primary IgAN at risk for disease progression.
Approval was based on proteinuria reductions in the phase 3 I CAN trial; whether ravulizumab slows kidney function decline has not been established.
At week 34, UPCR decreased 46.6% from baseline with ravulizumab and 5.6% with placebo; the placebo-adjusted treatment effect was 43.4%.
Common adverse events with ravulizumab included upper respiratory tract infection, nasopharyngitis, and infusion-related reactions.
Ravulizumab carries a boxed warning for serious meningococcal infections, including potentially fatal infections.

Guideline-Based Recommendations

Diagnosis

Management

The FDA-approved indication is reduction of proteinuria in adults with primary IgAN at risk for disease progression.
The I CAN trial enrolled participants receiving stable standard-of-care treatment for at least 3 months.
Ravulizumab is administered intravenously using weight-based dosing, with a loading dose followed by maintenance dosing every 8 weeks.

Monitoring & Follow-up

Complete or update meningococcal vaccination at least 2 weeks before treatment initiation unless delaying therapy poses greater risks.
Monitor patients for early signs and symptoms of meningococcal infection; susceptibility may persist despite vaccination.
The ongoing I CAN trial will assess change in eGFR at week 106.

Risks

Ravulizumab has a boxed warning for serious, potentially fatal meningococcal infections.
Frequently reported adverse events with ravulizumab included upper respiratory tract infection (11.3%), nasopharyngitis (9.2%), and infusion-related reactions (8.4%).

Patient & Prescribing Data

Adults with primary IgAN at risk for disease progression; the I CAN trial studied participants on stable standard-of-care treatment for at least 3 months.

Intravenous, weight-based dosing begins with a loading dose followed by maintenance doses every 8 weeks. Meningococcal vaccination should be completed or updated at least 2 weeks before initiation unless delaying treatment poses greater risks.

Clinical Best Practices

Assess meningococcal vaccination status before starting ravulizumab and complete or update vaccination at least 2 weeks before treatment unless delaying therapy poses greater risks.
Monitor for early signs and symptoms of meningococcal infection even after vaccination.
Do not interpret proteinuria reduction as established evidence that ravulizumab slows kidney function decline; that outcome remains under evaluation in the ongoing I CAN trial.