The U.S. Food and Drug Administration on Tuesday granted accelerated approval to Vera Therapeutics Inc.’s (NASDAQ:VERA) Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
Following the announcement, the stock jumped nearly 9%.
The approval was supported by interim Phase 3 data showing statistically significant reductions in proteinuria compared with placebo. Trutakna is approved under the FDA’s accelerated approval pathway based on its ability to reduce proteinuria.
The company noted that long-term evidence demonstrating whether the treatment slows kidney function decline has not yet been established. Continued approval may depend on confirmation of clinical benefit in the ongoing ORIGIN 3 study.
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