FDA Approves First Dual BAFF/APRIL Drug for IgA Nephropathy
The FDA granted accelerated approval to TRUTAKNA (atacicept), the first dual BAFF/APRIL inhibitor for IgA nephropathy, after cutting proteinuria 46% at 36 weeks.
TL;DR — The FDA granted accelerated approval to Vera Therapeutics’ TRUTAKNA (atacicept) — the first and only dual BAFF/APRIL inhibitor for IgA nephropathy — after it cut proteinuria 46% from baseline at 36 weeks, and 42% versus placebo.
Patients with a progressive kidney disease got a new option this week. On July 7, 2026, the FDA granted accelerated approval to TRUTAKNA.
The approval
The FDA granted accelerated approval to Vera Therapeutics’ TRUTAKNA (atacicept) — described as the first and only dual BAFF/APRIL inhibitor for primary IgA nephropathy (IgAN), a progressive kidney disease. In the pivotal ORIGIN 3 trial, atacicept reduced proteinuria by 46% from baseline at the 36-week interim analysis, and by 42% versus placebo (p<0.0001). It is dosed at 150 mg subcutaneously, once weekly, via autoinjector.
| Metric | Result |
|---|---|
| Proteinuria vs. baseline (36 wks) | −46% |
| Vs. placebo | −42% (p<0.0001) |
| Dosing | 150 mg weekly, subcutaneous |
| Approval basis | Accelerated (proteinuria surrogate) |
What they said
"The approval of TRUTAKNA as the first and only BAFF and APRIL inhibitor for IgAN marks an important milestone." — Marshall Fordyce, M.D., Founder & CEO, Vera Therapeutics
Why it matters
- Two pathways, one drug. Blocking both BAFF and APRIL differentiates it from single-pathway rivals.
- A crowded field. IgAN now has several competing mechanisms, including complement-targeted options.
- Accelerated, not final. Approval rests on a proteinuria surrogate; confirmatory kidney-function data are still to come.
FAQ
What is TRUTAKNA (atacicept) approved for?
The FDA granted accelerated approval on July 7, 2026 for TRUTAKNA (atacicept) to treat adults with primary IgA nephropathy — the first and only dual BAFF/APRIL inhibitor for the disease.
How well did atacicept work in trials?
In the pivotal ORIGIN 3 trial, it reduced proteinuria by 46% from baseline at a 36-week interim analysis and by 42% versus placebo (p<0.0001). Approval is accelerated, based on that surrogate endpoint, with confirmatory kidney-function data still pending.
Sources
- GlobeNewswire — Vera Therapeutics receives FDA accelerated approval for TRUTAKNA
- BioPharma Dive — FDA approves Vera’s TRUTAKNA
Image: “U.S. Food and Drug Administration office” by CaptJayRuffins, CC BY-SA 4.0, via Wikimedia Commons.
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