The U.S. FDA approved Vera Therapeutics’ atacicept fusion protein, branded Trutakna, for adults with primary IgA nephropathy (IgAN). The accelerated approval makes Trutakna the first dual BAFF/APRIL inhibitor in the indication, with the label based on reduction in proteinuria. The FDA’s decision gives Vera a commercial head start and sets up an impending competitive landscape with Otsuka’s kidney disease therapy, which entered the market last year. Vera’s Trutakna is dosed once weekly via auto-injector. A confirmatory study (Origin 3) is already underway, with readouts expected in the third quarter, which will determine whether Trutakna’s effect on proteinuria translates into slower kidney function decline over longer follow-up.
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