Trutakna won FDA accelerated approval to reduce proteinuria in adults with primary IgA nephropathy who are at risk of disease progression.
ORIGIN 3 data drove the decision: among the first 203 patients reaching week 36, atacicept cut proteinuria 46% from baseline and 42% versus placebo, with P<.0001.
The drug is the first BAFF and APRIL inhibitor approved for IgAN and is given as a 150 mg weekly subcutaneous autoinjector that patients may self-administer at home.
Common side effects were upper respiratory infection and injection-site reactions, while labeling warns of higher infection risk from immunosuppression.
Continued approval depends on confirmatory evidence from the ongoing ORIGIN 3 trial, which is tracking kidney-function change over 2 years, with eGFR results expected in Q3 2026.
Could this new kidney drug's unique mechanism unlock treatments for other autoimmune diseases?
Can a 42% protein reduction truly halt the journey to kidney failure for patients with IgAN?
With a new at-home injection approved, will its cost become the biggest hurdle for patients?
TRUTAKNA Approved for IgA Nephropathy: First Dual BAFF/APRIL Inhibitor Targets Disease Progression, Awaiting Confirmatory Results
Overview
On July 7, 2026, the FDA granted accelerated approval to TRUTAKNA™ (atacicept-vymj) for adults with primary IgA nephropathy (IgAN) at risk for disease progression. TRUTAKNA is a new treatment that works by targeting and binding to both BAFF and APRIL, two cytokines that play a key role in the development of IgAN by affecting B-cell activity and immunoglobulin production. This dual action offers a unique way to address the disease’s underlying immune causes. Early clinical results showed TRUTAKNA reduces proteinuria, but its long-term effect on slowing kidney function decline is still being studied.