Vera Therapeutics has received accelerated FDA approval for atacicept to treat adults with the autoimmune kidney disease primary IgA nephropathy. The recombinant fusion protein therapy will now be marketed as Trutakna—with a clean label, analysts noted—and compete with Otsuka’s Voyxact and Novartis’ Fabhalta.

The therapy was specifically approved to lower proteinuria in patients who have primary IgAN and are at risk of further disease progression. In an interim analysis from the ongoing Phase 3 trial ORIGIN 3, patients who received Trutakna achieved a 46% reduction from baseline in proteinuria, a key biomarker of the disease when protein builds up in the urine. As compared to placebo, the reduction was 42% at 36 weeks.