FDA Approves Trutakna (Atacicept) for Adults with IgA Nephropathy

Trutakna is the first FDA-approved IgA nephropathy therapy to target both BAFF and APRIL, two immune proteins involved in abnormal antibody activity.

IgA nephropathy can silently damage the kidneys for years before it progresses to kidney failure. The National Kidney Foundation reports that about one in five people with the condition develop kidney failure within 10 years of diagnosis. Now, the FDA has approved a new treatment that targets immune pathways involved in the disease.

The FDA granted accelerated approval to Vera Therapeutics’ Trutakna (atacicept-vymj). The drug is approved to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

Proteinuria occurs when too much protein leaks into the urine. This can be a sign that the kidney’s filtering system is being damaged.

Trutakna is the first FDA-approved medicine for IgAN that targets both B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL). These immune system proteins help certain immune cells survive and mature.

By blocking both proteins, Trutakna aims to reduce the production of abnormal IgA antibodies that contribute to kidney inflammation and damage.

Vera Therapeutics is a commercial-stage biotechnology company based in Brisbane, California, focused on treatments for serious immunological diseases.

Trutakna is given as a 150 mg subcutaneous (under-the-skin) injection once weekly. Patients can self-administer the treatment at home using an autoinjector.

IgAN, also known as Berger’s disease, occurs when abnormal IgA antibodies build up in the kidneys. This buildup can inflame and damage the glomeruli, the tiny filtering units that help remove waste from the blood. Over time, that damage can lead to proteinuria and declining kidney function. In some patients, it can lead to the need for dialysis or a kidney transplant.

Trutakna’s approval was supported by data from ORIGIN 3. ORIGIN 3 is an ongoing global Phase III trial in adults with biopsy-confirmed IgAN. Participants were assigned to receive either Trutakna 150 mg once weekly or a placebo. The interim analysis measured changes in the 24-hour urine protein-to-creatinine ratio, which helps show how much protein is leaking into the urine over a full day.

At 36 weeks, patients treated with Trutakna showed a 46% reduction in proteinuria from their baseline levels. Compared with the placebo group, Trutakna reduced proteinuria by 42%. The company described this result as statistically significant and clinically meaningful. The nine-month analysis included the first 203 patients who had the opportunity to reach that visit.

The FDA granted Trutakna accelerated approval because it reduced proteinuria. This FDA pathway can speed up access to drugs for serious conditions. It uses early results, like lower urine protein levels, that are reasonably likely to predict a clinical benefit.

The ongoing ORIGIN 3 trial is studying whether Trutakna can slow kidney function decline over time, with results expected in the third quarter of 2026. Vera expects these results in the third quarter of 2026. Continued approval may depend on confirming this longer-term benefit.

Trutakna also received Priority Review and Breakthrough Therapy designation for this indication. Its approval adds another option to the growing IgAN treatment landscape.

IgAN drug development is moving quickly. Otsuka’s Voyxact (sibeprenlimab-szsi), a selective APRIL inhibitor, received FDA accelerated approval in November 2025. The drug recently showed positive two-year kidney function results in the Phase III VISIONARY trial. Meanwhile, Vertex Pharmaceuticals is developing povetacicept, another dual BAFF and APRIL inhibitor. The FDA accepted its BLA in June 2026, with a target action date set for November 30, 2026.

FAQs

Is Trutakna a gene therapy or an antibiotic?

No. Trutakna is not a gene therapy, cell therapy or antibiotic. It is an immune-targeting biologic that blocks BAFF and APRIL, two proteins involved in the disease process behind IgA nephropathy.

What does accelerated approval mean for Trutakna?

Accelerated approval means the FDA approved Trutakna based on an early marker, in this case reduced proteinuria, that is reasonably likely to predict clinical benefit. The ongoing trial is still studying whether the drug slows kidney function decline over time.

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