Vera Therapeutics, Inc. (Nasdaq: VERA) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to TRUTAKNA™ (atacicept-vymj). The therapy is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
TRUTAKNA is the first and only available therapy that binds both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). By inhibiting these two cytokines, it directly targets the B cells at the source of IgAN pathophysiology. Administered as a 150 mg once-weekly subcutaneous injection via an at-home autoinjector, TRUTAKNA offers patients a novel treatment approach for this progressive, immune-mediated kidney disease.
The approval is based on a prespecified 36-week interim analysis of the ongoing Phase 3 ORIGIN 3 trial. Participants treated with TRUTAKNA achieved a 46% reduction from baseline in proteinuria, demonstrating a statistically significant 42% net reduction compared to the placebo group ().
The therapy was generally well tolerated, with mild-to-moderate infections and local administration reactions being the most common adverse events. Continued approval remains contingent upon verification of clinical benefit in the ongoing trial, with key eGFR kidney function data anticipated in Q3 2026.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
