FDA Approves Atacicept (Trutakna) for IgA Nephropathy

The FDA granted accelerated approval on July 7, 2026 to atacicept, sold under the brand name Trutakna, for adults with primary IgA nephropathy (IgAN) who are at risk of their kidney disease getting worse. It is the latest in a small but growing group of targeted therapies for this autoimmune kidney condition.

IgA nephropathy, sometimes called Berger's disease, happens when the immune system produces abnormal IgA antibodies that clump together and become trapped in the kidneys' filtering units. Over time, that buildup triggers inflammation and scarring that can progressively damage kidney function, and a meaningful share of patients eventually progress to kidney failure requiring dialysis or transplant.

Atacicept works upstream of that process. It is a recombinant fusion protein that binds to and blocks two signaling proteins, BAFF and APRIL, that B cells rely on to survive and to keep producing the abnormal antibodies implicated in IgAN. By interrupting that signal, the drug aims to reduce production of the harmful antibodies at the source rather than just treating their downstream effects.

The approval is based on an interim analysis of the ongoing Phase 3 ORIGIN 3 trial, in which patients treated with atacicept saw a 46 percent reduction in proteinuria (protein leaking into the urine, a key marker of kidney damage) from baseline, a statistically significant 42 percent reduction compared to placebo at 36 weeks. In the trial, atacicept was generally well tolerated, with the most common side effects being infections and reactions at the injection site.

Because this is an accelerated approval, it is based specifically on the drug's ability to reduce proteinuria rather than on direct proof that it slows the long-term decline of kidney function. The FDA sometimes grants this faster pathway for serious diseases with real unmet need, on the condition that the company continues studying the drug to confirm the clinical benefit. Vera Therapeutics will need to verify in a confirmatory trial that the proteinuria reduction translates into meaningfully preserved kidney function over time; if it does not, the approval could eventually be revisited.

For patients, the practical significance is that atacicept becomes another treatment option for a disease that, until recently, had very few targeted therapies and was often managed mainly by controlling blood pressure and slowing progression with general kidney-protective drugs. IgA nephropathy is considered one of the most common causes of primary glomerular disease worldwide, and a substantial number of patients continue to lose kidney function despite existing treatments, so an additional mechanism aimed specifically at the antibody-producing process addresses a real gap in care.

Vera Therapeutics has said it plans to make Trutakna available to patients following the standard post-approval rollout process, and prescribers will be able to use it alongside supportive care already recommended for IgAN. As with any newly approved biologic, real-world data collected after launch will help clarify how the drug performs and who benefits most outside the more controlled conditions of a clinical trial.