FDA Alert

FDA Approves Trutakna for Primary IgA Nephropathy

Edited by:
Ashton L. Stahl

Key Highlights

  • Atacicept-vymj (Trutakna) was approved to reduce proteinuria in adults with primary immunoglobulin A nephropathy.
  • The approval was based on a randomized, double-blind, placebo-controlled trial in adults with biopsy-confirmed IgA nephropathy.
  • At 9 months, patients receiving Trutakna had an average 46% reduction in proteinuria compared with placebo.
  • The FDA granted accelerated approval, and continued approval may depend on confirmatory evidence of long-term clinical benefit.

On July 7, the FDA approved atacicept-vymj (Trutakna, Vera Therapeutics, Inc.) to reduce proteinuria in adults with primary immunoglobulin A nephropathy who are at risk for disease progression. The FDA described IgA nephropathy as a serious kidney disease in which abnormal immunoglobulin A builds up in the kidneys, leading to inflammation, kidney damage, proteinuria, and potential loss of kidney function over time.

A randomized, double-blind, placebo-controlled clinical trial in adults with biopsy-confirmed IgA nephropathy supported the approval. Patients were randomly assigned to receive atacicept-vymj 150 mg by subcutaneous injection once weekly or a placebo. The primary efficacy endpoint was change from baseline in proteinuria, measured by urine protein-to-creatinine ratio from a 24-hour urine collection, after 9 months of treatment in the first 203 patients eligible for the month 9 visit. At 9 months, patients receiving atacicept-vymj had an average 46% reduction in proteinuria compared with placebo.

Atacicept-vymj suppresses the immune system and may increase the risk of infection. Patients should be assessed for active infections before starting treatment and monitored for signs of infection during treatment. Live vaccines are not recommended within 30 days before starting atacicept-vymj or during treatment.

The recommended dosage in the FDA release is atacicept-vymj 150 mg, administered subcutaneously once weekly. The FDA granted accelerated approval based on a reduction in proteinuria, and the ongoing clinical trial must be completed to confirm whether atacicept-vymj slows long-term decline in kidney function in patients with IgA nephropathy.

References

Food and Drug Administration. FDA approves new treatment to reduce proteinuria in adults with primary immunoglobulin A nephropathy. FDA. Published July 7, 2026. Accessed July 15, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-treatment-reduce-proteinuria-adults-primary-immunoglobulin-nephropathy