FDA grants accelerated approval to Vera Therapeutics' kidney drug

Vera Therapeutics (Nasdaq: VERA) announced on July 7, 2026, that the U.S. Food and Drug Administration granted accelerated approval to TRUTAKNA (atacicept-vymj) to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk for disease progression.

The approval is based on a prespecified interim analysis of the ongoing ORIGIN 3 Phase 3 trial, in which participants treated with TRUTAKNA achieved a 46% reduction from baseline in proteinuria and a 42% reduction compared to placebo (p<0.0001) at 36 weeks. The interim analysis covered the first 203 participants who had received at least one dose of TRUTAKNA or placebo.

TRUTAKNA is a fusion protein that binds both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). It is self-administered via autoinjector at a dose of 150 mg subcutaneously once weekly.

The FDA's accelerated approval is based on proteinuria reduction as a surrogate endpoint. It has not been established whether TRUTAKNA slows kidney function decline over the long term. Continued approval may be contingent on results from the ongoing ORIGIN 3 trial evaluating estimated glomerular filtration rate (eGFR), with results anticipated in the third quarter of 2026.

In the ORIGIN 3 safety population of 428 patients, the most common adverse reactions in TRUTAKNA-treated patients versus placebo were infections (32% vs. 28%) and local administration reactions (30% vs. 5%). The most common infection was upper respiratory tract infection (12% vs. 9%).

IgAN affects an estimated 160,000 patients in the U.S. Globally, approximately 2.5 adults per 100,000 are diagnosed with the condition each year, most often between ages 30 and 40. At least 50% of patients may progress to kidney failure or death within 10 to 20 years of diagnosis, according to published data cited in the press release.

TRUTAKNA is contraindicated in patients with serious hypersensitivity to atacicept-vymj or any of its excipients. The safety and effectiveness of TRUTAKNA in pediatric patients have not been established.

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