FDA Grants Accelerated Approval to Vera Therapeutics' Trutakna as First Dual BAFF and APRIL Inhibitor for IgA Nephropathy

FDA Grants Accelerated Approval to Vera Therapeutics' Trutakna as First Dual BAFF and APRIL Inhibitor for IgA Nephropathy

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 immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. Administered once weekly via a 150 mg subcutaneous self-injection at home, Trutakna is the first and only approved therapy that binds both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), directly targeting the immunological drivers of the disease.

The accelerated approval was supported by a prespecified 36-week interim analysis from the ongoing, global, randomized, double-blind, placebo-controlled Phase 3 ORIGIN 3 trial (NCT04716231). In the first 203 randomized participants, those treated with Trutakna achieved a 46% reduction from baseline in the 24-hour urine-protein-to-creatinine-ratio (UPCR), translating to a highly statistically significant and clinically meaningful 42% reduction compared to placebo (p<0.0001). Additionally, patients treated with Trutakna experienced a 68% reduction in galactose-deficient IgA1 (Gd-IgA1), a key disease biomarker.

Confirmatory eGFR Trial Status

Because this indication is approved under the accelerated pathway based on the surrogate endpoint of proteinuria reduction, continued approval is contingent upon verification of clinical benefit.¹ The ongoing, fully blinded, placebo-controlled Phase 3 ORIGIN 3 trial continues to evaluate the drug's impact on kidney function decline as measured by estimated glomerular filtration rate (eGFR). Topline confirmatory eGFR results are highly anticipated in Q3 2026.

Safety and Tolerability Profile

The safety database for Trutakna includes 428 patients randomized to either the active drug or placebo. The therapy was generally well tolerated, with most adverse reactions being mild-to-moderate and resolving without treatment interruption:

• Infections: 32% in the Trutakna group vs. 28% in the placebo group (most commonly upper respiratory tract infections at 12% vs. 9%). No serious, severe, or opportunistic infections were reported.
• Local administration reactions: 30% in the Trutakna group vs. 5% in the placebo group (most commonly injection site reactions at 19% vs. 2%).