Trutakna Approved for Immunoglobulin A Nephropathy
On July 7, 2026, the US Food and Drug Administration (FDA) granted accelerated approval to Vera Therapeutics’ Trutakna™ (atacicept-vymj) to reduce proteinuria in adults who have primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. Trutakna is the first dual B-cell activating factor (BAFF) and A Proliferation-Inducing Ligand (APRIL) inhibitor and is designed to target upstream immune pathways involved in the production of IgA antibodies that contribute to kidney damage. The recommended dose is 150mg administered subcutaneously (SC) once weekly using an autoinjector. The FDA approved Trutakna under its accelerated approval pathway based on reductions in proteinuria. Continued approval depends on results from the ongoing ORIGIN 3 trial, which must confirm that Trutakna slows long-term kidney function decline in patients with IgAN. Results are expected in the third quarter of 2026. A launch date has not yet been announced. Cost information is not yet available. Here is the prescribing information.
At a Glance
- Brand Drug: Trutakna™ (atacicept-vymj)
- Manufacturer: Vera Therapeutics
- Date Approved: July 7, 2026
- Indication: To reduce proteinuria in adults who have primary IgAN at risk for disease progression
- Dosage Forms Available: 150mg/mL SC injection in a single-dose pre-filled autoinjector
- Launch Date: Unknown at this time
- Estimated Annual Cost: Not yet known
- FDA Designation: Accelerated Approval. Breakthrough Therapy. Priority Review.
- IgAN is a progressive, autoimmune kidney disease characterized by deposition of IgA antibodies in the kidneys, leading to proteinuria. Over time, IgAN can lead to a gradual decline in kidney function and as many as 40% of patients progress to end-stage renal disease (ESRD) within 10 years, eventually needing dialysis or a kidney transplant.
- Approximately 160,000 patients are estimated to have IgAN in the United States.
- Approval was supported by data demonstrating that Trutakna achieved a 46% reduction from baseline in proteinuria and a statistically significant 42% reduction versus placebo at 36 weeks. The most common adverse reactions were infections and local administration-site reactions.
- Several drugs are currently available to treat IgAN including angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), sodium-glucose cotransporter 2 (SGLT2) inhibitors and endothelin receptor antagonists [ERAs; including Filspari® (sparsentan – Travere Therapeutics) and Vanrafia® (atrasentan – Novartis)]. Tarpeyo® (budesonide – Calliditas Therapeutics), a corticosteroid, Fabhalta® (iptacopan – Novartis), a complement pathway inhibitor, and Voyxact® (sibeprenlimab-szsi – Otsuka), an APRIL inhibitor, are additional treatment options.
- To date, only Filspari and Tarpeyo have received full FDA approval to reduce the loss of kidney function with IgAN. Trutakna, Voyxact, and Vanrafia were approved under the FDA’s accelerated approval pathway based on reductions in proteinuria.
- In the pipeline, Vertex Pharmaceuticals’ povetacicept, another dual APRIL/BAFF inhibitor, is in development for IgAN with approval possible by Nov. 30, 2026. It’s administered as a SC injection every four weeks. Novartis’ zigakibart is an APRIL inhibitor in phase III development for IgAN with approval possible in the second half of 2027. It’s administered as a SC injection every two weeks.