FDA approves ravulizumab for IgA nephropathy

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

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The FDA granted accelerated approval to ravulizumab-cwvz to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression.
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Approval was based on the phase 3 I CAN trial, in which ravulizumab reduced proteinuria by 46.6% at week 34, compared with 5.6% with placebo.
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Whether ravulizumab slows kidney function decline has not been established; the ongoing I CAN trial will assess eGFR change at week 106.
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The most frequently reported adverse events with ravulizumab were upper respiratory tract infection, nasopharyngitis, and infusion-related reactions.
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Ravulizumab carries a boxed warning for serious meningococcal infections, and the FDA advises vaccination before treatment unless delaying therapy poses greater risks.

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