FDA Grants Accelerated Approval to Vera Therapeutics' Trutakna with Promising eGFR Data Disclosed
On July 7, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Vera Therapeutics' Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary IgA nephropathy (IgAN) who are at risk of rapid disease progression. Trutakna is a first-in-class dual inhibitor of B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), designed to target the underlying autoimmune mechanisms of IgAN.
While the accelerated approval was based on proteinuria reduction, a key question for investors and clinicians was whether Trutakna could demonstrate a long-term benefit in preserving kidney function, measured by the estimated glomerular filtration rate (eGFR).
Summary Basis for Approval Discloses Strong eGFR Profile
On August 13, 2026, the FDA released its official Summary Basis for Approval document for Trutakna, which revealed highly encouraging kidney-preservation data from the pivotal Phase 3 ORIGIN 3 study:
- eGFR Stabilization: Patients treated with Trutakna showed "impressive" and "promising" stabilization of eGFR through 52 weeks of treatment. This finding matches the competitive profile of Otsuka Pharmaceuticals' Voyxact (sibeprenlimab), which previously generated excitement by demonstrating similar eGFR stabilization.
- Early eGFR "Bump": Analysts noted an initial eGFR improvement or "bump" at week four, followed by a relatively flat trajectory through 52 weeks, comparing favorably to Voyxact's clinical data.
- Long-Term Preservation: Although based on a smaller cohort of patients, additional 60-week and 72-week data continue to show sustained kidney function stabilization.
While the FDA noted that the eGFR data was based on a limited number of patients and was ultimately insufficient to support full approval on its own at this stage, the findings significantly de-risk Trutakna's competitive position. The finalized, comprehensive eGFR analysis from the ORIGIN 3 trial is scheduled to be presented at a medical congress later this year and will serve as the confirmatory evidence required for full FDA approval.