Vera Therapeutics Wins FDA Accelerated Approval For TRUTAKNA In Primary IgA Nephropathy
(RTTNews) – Vera Therapeutics, (VERA), a commercial-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) granted TRUTAKNA (atacicept-vymj) accelerated approval to reduce proteinuria in adults with primary IgA nephropathy or IgAN at risk for disease progression.
IgA Nephropathy is a serious, progressive, immune-mediated kidney disease and a leading cause of chronic kidney disease and kidney failure worldwide. The company estimates that approximately 2.5 adults per 100,000 are diagnosed with IgAN each year, most often between 30 and 40 years of age.
Atacicept is a recombinant fusion protein designed to inhibit B-cell activation by binding to B-cell activating factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), two cytokines implicated in the progression of autoimmune kidney disease. The approved TRUTAKNA dose is 150 mg injected subcutaneously once weekly, self-administered via an autoinjector.
In the prespecified interim analysis of the ongoing ORIGIN 3 trial, participants treated with TRUTAKNA achieved a 46% reduction in proteinuria from baseline, with a statistically significant and clinically meaningful 42% reduction compared to placebo at 36 weeks.
Notably, this accelerated approval is based on the reduction of proteinuria. It has not been established whether TRUTAKNA slows the decline in kidney function over the long term in patients with IgAN.
Continued approval depends on verification and description of clinical benefit in the ongoing ORIGIN 3 trial, a randomised, double-blind, placebo-controlled trial evaluating changes in kidney function, as measured by estimated glomerular filtration rate (eGFR), with results anticipated in the third quarter of 2026.
According to Future Market Insights Inc., the IgAN market size is estimated to reach $50.38 billion in 2026 and $107.23 billion in 2036.
TRUTAKNA now enters a competitive IgAN market that includes Filspari (sparsentan) from Travere Therapeutics, Tarpeyo (budesonide) from Calliditas Therapeutics, Fabhalta (iptacopan) and Vanrafia (atrasentan) from Novartis, and Voyxact (sibeprenlimab) from Otsuka.
VERA has traded between $19.07 and $56.05 over the last year. The stock closed Tuesday’s trade at $42.96, up 7.05%.
VERA is currently up 0.09% to $43 in after-hours trading.
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