Vera Therapeutics' BAFF/APRIL Inhibitor TRUTAKNA Wins FDA Accelerated Approval in IgAN

Vera Therapeutics' BAFF/APRIL Inhibitor TRUTAKNA Wins FDA Accelerated Approval in IgAN

On July 7, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Vera Therapeutics' TRUTAKNA (atacicept-vymj) subcutaneous injection (150 mg once weekly) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of rapid disease progression.

TRUTAKNA is a soluble recombinant fusion protein that binds to and inhibits two key cytokines: B-cell activating factor (BAFF) and A Proliferation-Inducing Ligand (APRIL). These cytokines drive the survival and maturation of B cells that produce the autoantigen Gd-IgA1, which forms the inflammatory immune complexes that damage the kidneys in IgAN. TRUTAKNA is the first and only FDA-approved therapy that targets both BAFF and APRIL, addressing the disease at its immunological source.

Pivotal Phase 3 Trial Supporting Approval

The accelerated approval was supported by interim proteinuria data from the ongoing global Phase 3 ORIGIN 3 trial (NCT04716231). In the trial, patients randomized to receive weekly subcutaneous injections of TRUTAKNA achieved a 45.7% reduction in proteinuria at week 36 compared to baseline, representing a highly statistically significant and clinically meaningful improvement over placebo. The safety and efficacy data from the Phase 3 trial were published in The New England Journal of Medicine (NEJM) in 2026.

As stated in the official FDA approval announcement:

"Trutakna is the first FDA-approved medicine that targets both B cell activating factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which are involved in survival and maturation of certain immune cells... Trutakna was granted accelerated approval based on the reduction in proteinuria.¹"

Vera Therapeutics' Founder and CEO, Marshall Fordyce, M.D., emphasized the significance of the regulatory decision:

“The approval of TRUTAKNA as the first and only BAFF and APRIL inhibitor for IgAN marks an important milestone and we believe it has the potential to meaningfully transform the treatment landscape.”

Market Context and Next Steps

The approval sets up a highly competitive market battle in the IgAN space, where TRUTAKNA will compete directly with Novartis's Fabhalta (iptacopan) and Filspari (sparsentan). To support full, traditional regulatory approval, Vera is conducting the confirmatory portion of the Phase 3 ORIGIN 3 trial, with key glomerular filtration rate (eGFR) kidney function data expected to read out in Q3 2026. This data will be critical to confirming whether the reduction in proteinuria translates to long-term preservation of kidney function.