The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Trutakna™ (atacicept-vymj) for adults with primary IgA nephropathy, or IgAN, who are at risk for their disease getting worse.

Trutakna is approved to reduce proteinuria, which means having too much protein in the urine. Proteinuria is one of the key signs doctors use to track kidney stress and IgAN progression.

This is important news for the IgAN community, but it comes with an important note: Trutakna has not yet been proven to slow long-term kidney function decline. The ongoing ORIGIN 3 trial is still studying whether the medication helps protect kidney function over time.

What Is Trutakna?

Trutakna is a prescription medication used to reduce protein in the urine in adults with primary IgAN who are at risk for disease progression.

It is given as a 150 mg injection under the skin once a week. According to the prescribing information, the medication comes in a single-dose prefilled autoinjector and may be given at home by patients or caregivers after proper instruction from a healthcare provider.

Trutakna is not a cure for IgAN. It is also not right for everyone with IgAN. Your doctor will need to look at your kidney function, urine protein levels, diagnosis, current medications, infection risk, and overall health before deciding whether it may be appropriate for you.

What Makes This Medication Different?

Trutakna is the first FDA-approved medicine for IgAN that targets both BAFF, also called BLyS, and APRIL. These are immune system signals involved in the survival and activity of certain immune cells.

In IgAN, the immune system makes an abnormal form of IgA. This can lead to deposits in the kidneys, causing inflammation and damage over time. By targeting BAFF/BLyS and APRIL, Trutakna is designed to reduce the production of abnormal IgA involved in IgAN.

This approach is different from treatments that mainly focus on lowering blood pressure, reducing kidney stress, or broadly calming inflammation. It targets part of the immune pathway believed to play a role in IgAN.

What Did the Study Show?

The FDA approval was based on results from the ongoing ORIGIN 3 clinical trial. This trial studied adults with biopsy-confirmed IgAN.

In a planned interim analysis, people who received Trutakna had a significant reduction in proteinuria after about 9 months of treatment. Vera Therapeutics reported that patients taking Trutakna had a 46% reduction from baseline in proteinuria and a 42% reduction compared with placebo at 36 weeks.

These results are encouraging because lowering proteinuria is an important goal in IgAN care. Higher protein levels in the urine are linked with a greater risk of kidney disease progression.

What Does Accelerated Approval Mean?

Accelerated approval allows the FDA to approve a medication sooner for a serious condition when early results suggest likely benefit.

In this case, Trutakna was approved because it reduced proteinuria. But the FDA requires more data to confirm whether the medication provides a longer-term clinical benefit, such as slowing kidney function decline.

What Should You Ask Your Doctor?

If you have IgAN, you may want to ask your nephrologist:

• Am I at risk for IgAN progression?
• What are my latest proteinuria and eGFR results?
• Could Trutakna be appropriate for my type of IgAN?
• How would this fit with my current medications?
• What infection risks should I know about?
• Do I need any vaccines before starting treatment?
• How would I be trained to use the autoinjector?
• How often would I need lab work or follow-up visits?

Do not start, stop, or change any IgAN treatment without talking with your healthcare provider.

Where Can You Learn More About IgAN?

Learning more about IgAN can help you feel more prepared for doctor visits and treatment decisions. For patient-friendly education, tools, and support, visit the IgA Nephropathy Foundation, one of our trusted partners.

The IgAN Foundation offers resources for people living with IgAN and their families, including guides, tracking tools, patient education, and community support.

Sources: 

• HCPLive. (July 7, 2026) “FDA Approves Atacicept (Trutakna) for IgA Nephropathy.” hcplive.com
• Vera Therapeutics. “Vera Therapeutics Receives FDA Accelerated Approval for TRUTAKNA™ for Adult Patients with Primary IgA Nephropathy.” ir.veratx.com

The information provided by Responsum for CKD is for educational purposes only and does not replace professional medical advice. Always talk with your nephrologist or other qualified healthcare provider before making changes to your treatment or kidney care. Responsum for CKD does not endorse specific treatments, providers, or products.