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# Vera Therapeutics' Trutakna Approved for IgA Nephropathy
- URL: https://www.fdaweb.com/vera-therapeutics-trutakna-approved-for-iga-nephropathy/
- Published: 2026-07-07T12:00:00.000Z
- Updated: 2026-09-14T13:42:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161417

FDA has granted Vera Therapeutics an accelerated approval for Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A (IgA) nephropathy who are at risk of disease progression, providing a new treatment option for patients with the chronic kidney disease.

The once-weekly subcutaneous injection’s approval was based on data from a randomized, double-blind, placebo-controlled Phase 3 trial involving adults with biopsy-confirmed IgA nephropathy. After nine months of treatment, patients receiving Trutakna achieved an average 46% reduction in proteinuria, compared with a 7% reduction in patients receiving placebo, according to FDA.

The agency granted accelerated approval based on the drug's effect on proteinuria, a surrogate endpoint reasonably likely to predict clinical benefit. FDA says it has not yet been established whether Trutakna slows long-term decline in kidney function, and the approval is contingent upon completion of an ongoing confirmatory trial designed to verify that benefit.

IgA nephropathy is a progressive kidney disease caused by the buildup of abnormal immunoglobulin A antibodies in the kidneys, leading to inflammation, protein leakage into the urine and, in some patients, eventual kidney failure.

The prescribing information includes warnings that Trutakna suppresses the immune system and may increase the risk of infections. Patients should be evaluated for active infections before initiating therapy and monitored throughout treatment, FDA says.