FDA Approves Trutakna as First Dual BAFF/APRIL Targeted Therapy for IgA Nephropathy

Vera Therapeutics’ Trutakna becomes the first FDA-approved therapy targeting both BAFF and APRIL pathways, introducing a new immune-based approach for adults with progressive IgA nephropathy.

The FDA has approved Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression, marking a significant advance in targeted immune therapy for kidney disease.

The approval is supported by the Phase III NCT04716231 trial, in which Trutakna achieved a 46% reduction in proteinuria compared with placebo after nine months of treatment, although further confirmatory studies are required to establish its long-term impact on kidney function decline.

Alert Type	Regulatory Approval (FDA)
Drug Name	Trutakna (atacicept-vymj)
Indication	Reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression
Therapy Area(s)	Nephrology, Immunology, Rare Disease, Kidney Disease
Geography	United States (FDA approval)
What Changed	The FDA approved Vera Therapeutics’ Trutakna (atacicept-vymj) for adults with primary IgA nephropathy at risk of disease progression. Trutakna is the first FDA-approved therapy targeting both B cell activating factor (BAFF) and A Proliferation Inducing Ligand (APRIL), two immune pathways involved in abnormal IgA antibody production. Approval was supported by Phase III data showing a 46% reduction in proteinuria compared with placebo after nine months of treatment.
Clinical Relevance	The approval introduces a new targeted immune approach for IgA nephropathy, a chronic kidney disease where abnormal antibody production contributes to inflammation, proteinuria and progressive kidney damage. Trutakna offers a potential new treatment option for patients at risk of disease progression, although long-term impact on kidney function decline remains under evaluation through confirmatory studies required under accelerated approval.
Source Link	https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-reduce-proteinuria-adults-primary-immunoglobulin-nephropathy
Date	02-Jul-2026
Status	Draft
Notes	Trutakna was granted accelerated approval, Priority Review and Breakthrough Therapy designation for this indication. The Phase III trial (NCT04716231) was a randomised, double-blind, placebo-controlled study in adults with biopsy-confirmed IgA nephropathy. Treatment involves a once-weekly 150mg subcutaneous injection. Safety considerations include increased infection risk due to immune suppression, with monitoring recommended during treatment. Continued approval is dependent on confirmation of long-term clinical benefit in slowing kidney function decline.

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