FDA grants accelerated approval to TRUTAKNA for IgA nephropathy
The U.S. Food and Drug Administration granted accelerated approval to TRUTAKNA (atacicept-vymj) to reduce proteinuria in adults with primary IgA nephropathy at risk for progression. Approval was based on a prespecified 36-week interim analysis of the global ORIGIN 3 Phase 3 trial, in which TRUTAKNA produced a 46% reduction from baseline in UPCR and a 42% reduction versus placebo (p<0.0001). TRUTAKNA was generally well tolerated, with infections and local administration reactions as the most common adverse events. Continued approval may require verification of long-term kidney function benefit in the ongoing eGFR analysis, expected Q3 2026.
TRUTAKNA reduced proteinuria 42% versus placebo at 36 weeks
Context
A global Phase 3 trial reported a large proteinuria drop at 36 weeks. The FDA used that result for accelerated approval. The trial will continue to measure kidney function and report eGFR results in Q3 2026.
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