FDA Grants Accelerated Approval to Vera Therapeutics’ TRUTAKNA for Treating Primary IgA Nephropathy

Vera Therapeutics, a commercial-stage biotech firm, announced that the FDA has granted accelerated approval to TRUTAKNA (atacicept‑vymj) for reducing proteinuria in adults with primary IgA nephropathy who are at risk of disease progression.

IgA nephropathy is a serious, progressive, immune‑mediated kidney disease and a leading cause of chronic kidney disease and kidney failure globally. Approximately 2.5 adults per 100,000 receive a diagnosis each year, typically between ages 30 and 40.

Atacicept is a recombinant fusion protein that blocks B‑cell activation by binding to BAFF and APRIL, cytokines involved in autoimmune kidney disease. The approved dose of TRUTAKNA is 150 mg administered subcutaneously once weekly via an autoinjector. In the prespecified interim analysis of the ongoing ORIGIN 3 trial, patients receiving TRUTAKNA showed a 46% reduction in proteinuria from baseline, with a statistically significant and clinically meaningful 42% greater reduction versus placebo at 36 weeks.

This accelerated approval hinges on the proteinuria reduction endpoint; it has not yet been demonstrated that TRUTAKNA slows long‑term decline in kidney function in IgA nephropathy patients.

Continued approval will depend on confirming clinical benefit in the ongoing ORIGIN 3 trial, a randomized, double‑blind, placebo‑controlled study assessing kidney function changes via estimated glomerular filtration rate (eGFR), with results expected in Q3 2026.

According to Future Market Insights Inc., the IgA nephropathy market is projected to reach $50.38 billion by 2026 and $107.23 billion by 2036.

TRUTAKNA enters a competitive IgA nephropathy landscape that includes Filspari (sparsentan) from Travere Therapeutics, Tarpeyo (budesonide) from Calliditas Therapeutics, Fabhalta (iptacopan) and Vanrafia (atrasentan) from Novartis, and Voyxact (sibeprenlimab) from Otsuka.

Over the past year, VERA’s shares have traded between $19.07 and $56.05, closing Tuesday’s session at $42.96, up 7.05%. In after‑hours trading, the stock was up 0.09% to $43.00.

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