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The FDA on July 7, 2026 granted accelerated approval to Trutakna (atacicept-vymj), Vera Therapeutics' once-weekly subcutaneous injection, to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression.
Atacicept is a TACI-Fc fusion protein that binds both B-cell activating factor and APRIL, reducing the signaling that drives production of galactose-deficient IgA1, the antibody implicated in the disease. Vera describes it as the only available therapy that blocks both ligands rather than one.
A prespecified interim analysis of Origin 3 assessed 106 patients on Trutakna and 97 on placebo at week 36. The urine protein-to-creatinine ratio fell 46% from baseline against 7% on placebo, a 42% reduction relative to placebo, at p<0.0001. Nearly every patient was already taking an ACE inhibitor or an ARB, and 53% an SGLT2 inhibitor. The drug is given at 150 mg weekly by autoinjector at home.
The label warns of immunosuppression and infection risk, and advises against live vaccines.
Atacicept is a Merck KGaA molecule the company set aside after repeated failures in other autoimmune diseases, out-licensed to Vera in October 2020. The approval rests on proteinuria, and whether the drug slows the decline in kidney function is not established in the labeled population.
Sources: FDA prescribing information; Drugs@FDA, BLA 761486; Vera Therapeutics press release; Merck KGaA out-licensing announcement; Fierce Pharma
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