Vera Therapeutics Secures FDA Accelerated Approval for TRUTAKNA to Treat Primary IgA Nephropathy

Vera Therapeutics has received accelerated approval from the US Food and Drug Administration (FDA) for TRUTAKNA (atacicept-vymj) to reduce proteinuria in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression. 

The approval marks an important step in expanding treatment options for patients with this progressive immune-mediated kidney disease.

The decision is supported by a pre-specified interim analysis of the ongoing Phase III ORIGIN 3 trial. 

Patients treated with TRUTAKNA achieved a 46% reduction in proteinuria from baseline and a statistically significant 42% greater reduction than placebo after 36 weeks of treatment (p<0.0001). 

The therapy is the first approved treatment that targets both BAFF and APRIL, two immune system proteins involved in the development of IgAN.

The ORIGIN 3 study enrolled adults with IgAN who received either TRUTAKNA 150 mg through once-weekly subcutaneous injections or placebo. 

Safety data from 428 participants showed that the therapy was generally well tolerated. The most frequently reported adverse events were infections and injection-site reactions, with most cases being mild to moderate.

The accelerated approval is based on proteinuria reduction, which is considered an important marker of disease activity.

Confirmation of long-term clinical benefit will depend on the ongoing ORIGIN 3 trial, which is evaluating kidney function decline using estimated glomerular filtration rate (eGFR), with results expected in the third quarter of 2026.