The U.S. Food and Drug Administration (FDA) has approved atacicept-vymj (Trutakna), a once-weekly injection, to reduce proteinuria (protein in the urine) in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

After nine months of treatment, people taking Trutakna had a 46 percent average reduction in proteinuria from the start of the clinical trial. Compared with a placebo (inactive treatment), Trutakna reduced proteinuria by an estimated 42 percent.

Proteinuria is a sign of kidney damage and is linked to a higher risk of losing kidney function over time. Higher proteinuria levels are linked to faster loss of kidney function, so reducing proteinuria may help reduce kidney damage over time. Trutakna’s long-term effect on kidney function hasn’t been confirmed yet.

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What Is Trutakna?

Trutakna is the first medication approved by the FDA that targets both B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL). These proteins help certain immune cells survive and mature. By blocking them, Trutakna helps decrease production of the abnormal IgA antibody involved in IgAN.

Trutakna is given as a subcutaneous injection once weekly.

What Did Clinical Trials Show?

The approval was based on a randomized, double-blind, placebo-controlled trial in adults with biopsy-confirmed IgAN. Participants received either Trutakna once weekly or a placebo (inactive treatment).

Randomized and double-blind mean participants were assigned by chance to receive either Trutakna once weekly or a placebo, and neither the participants nor the researchers knew who received which treatment during the study.

After nine months of treatment, people taking Trutakna had an average 46 percent reduction in proteinuria compared with a placebo.

Notably, this was an accelerated approval by the FDA. Research hasn’t yet established whether Trutakna can slow kidney function decline over the long term. Ongoing trials will need to show that longer-term benefit.

As with any treatment, Trutakna comes with a risk of side effects. For example:

• Upper respiratory tract infection
• Injection site reaction
• Injection site erythema

The label also warns that Trutakna weakens the immune system and may increase the risk of infections, and live vaccines aren’t recommended shortly before or during treatment.

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On myIgANteam, people share their experiences with IgAN, get advice, and find support from others who understand.

How often do you and your doctor talk about what caused your proteinuria and what makes it get better or worse? Let others know in the comments below.