FDA Approves Atacicept for IgA Nephropathy, Adding a Sixth Treatment Option

IgA nephropathy, also known as Berger disease, is the most common primary glomerular disease worldwide, affecting the tiny filtering units inside the kidneys. In this condition, an abnormal form of the immune protein immunoglobulin A (IgA) builds up in the kidney tissue, triggering inflammation that slowly causes scarring and a progressive decline in the kidney's ability to filter waste from the blood. At least half of people diagnosed with IgAN will eventually develop end-stage kidney disease, requiring dialysis or a kidney transplant. Until recently, treatment options were limited largely to medications that controlled blood pressure and reduced protein spilling into the urine, without directly targeting the underlying immune process driving the disease.

That landscape has changed significantly over the past two years. On July 7, 2026, the U.S. Food and Drug Administration granted accelerated approval to atacicept-vymj, sold under the brand name Trutakna and developed by Vera Therapeutics, making it the first dual BAFF and APRIL inhibitor approved for IgAN. BAFF and APRIL are two proteins in the immune system that support the survival and activity of the B cells and plasma cells responsible for producing the harmful IgA that accumulates in the kidneys. By blocking both simultaneously, atacicept works differently from previously approved therapies, which target only one of these pathways. This dual blockade may offer a more complete suppression of the upstream immune signals that drive disease activity.

The approval was built on data from the Phase 3 ORIGIN 3 trial, which enrolled 431 adults with biopsy-confirmed IgAN at sites worldwide. Patients were randomly assigned to receive either atacicept 150 mg or a placebo via a self-administered weekly subcutaneous injection they could give at home. At a prespecified 36-week interim analysis, patients on atacicept achieved a 46% reduction in urine protein-to-creatinine ratio from baseline, and a statistically significant 42% greater reduction compared to placebo. The primary investigator from Stanford University Medical Center described this as the largest placebo-adjusted proteinuria reduction reported by any Phase 3 IgAN trial at that time point. The most common adverse effects were infections, occurring in 32% of atacicept-treated patients versus 28% with placebo, and local injection-site reactions in 30% versus 5%.

Because the approval is accelerated, confirmatory data on kidney filtration rate (eGFR) decline are required for full approval. Following FDA alignment in June 2026 on a revised analysis plan, those pivotal eGFR results were pulled forward and are now expected in the third quarter of 2026. This approval lands just months after sibeprenlimab (Voyxact) received FDA accelerated approval in November 2025 based on a 51% placebo-adjusted proteinuria reduction in the Phase 3 VISIONARY trial. With atacicept's approval, patients with IgAN now have six FDA-approved treatment options, including iptacopan, sparsentan, budesonide, and atrasentan.

For patients and their nephrologists, the expanding treatment landscape means more options but also more complexity in choosing the right therapy. Atacicept's dual BAFF and APRIL mechanism may offer an advantage in certain patients, though head-to-head comparisons between the newer agents are not yet available. Anyone with IgAN should speak with their care team about current proteinuria levels, kidney function trends, and which of the available treatments might be the best fit for their situation. The pace of approvals in IgAN over the past two years reflects how much the science has advanced, and ongoing studies are expected to clarify which patients benefit most from each approach, bringing the field closer to genuinely personalized kidney care.