The U.S. Food and Drug Administration (FDA) has approved Trutakna (atacicept-vymj) to reduce proteinuria (excess protein in the urine) in adults with primary Immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. The approval provides a new treatment option for patients with this rare kidney disease, which can eventually lead to kidney failure.
Trutakna is administered as a once-weekly subcutaneous injection and received accelerated approval based on results from the Phase 3 ORIGIN clinical trial. Patients treated with Trutakna experienced a 42% greater reduction in proteinuria compared with placebo after 36 weeks, with an overall 46% reduction from baseline, indicating meaningful improvement in a key marker of kidney disease progression.
Trutakna is the first FDA-approved therapy that simultaneously targets the immune proteins BAFF and APRIL, which play a central role in the production of disease-causing antibodies in IgA nephropathy. By blocking both pathways, the drug aims to reduce immune-mediated kidney damage.
The approval is based on proteinuria reduction as a surrogate endpoint. The ongoing ORIGIN trial will continue to evaluate whether Trutakna slows the decline in kidney function, measured by estimated glomerular filtration rate (eGFR), with additional data expected later this year.
The FDA advises healthcare professionals to review the full prescribing information before initiating treatment, including recommended dosing, safety precautions, and monitoring requirements.
