GlobeNewswire·Jul 7, 2026, 12:37 PM ET

Vera Therapeutics Receives FDA Accelerated Approval for TRUTAKNA™ for Adult Patients with Primary IgA Nephropathy

The FDA granted accelerated approval to TRUTAKNA (atacicept-vymj) for reducing proteinuria in adults with primary IgA nephropathy at risk for disease progression.
TRUTAKNA is the first & only therapy binding both BAFF & APRIL to address immunological drivers of IgAN.
The approved dosage is 150 mg administered via subcutaneous self-injection once weekly.
In the ORIGIN 3 trial interim analysis, TRUTAKNA achieved a 46% reduction in proteinuria from baseline & a 42% reduction compared to placebo at 36 weeks.
Most common adverse reactions included infections (32%) & local administration reactions (30%).
Continued approval is contingent on verifying clinical benefit regarding kidney function decline in the ongoing ORIGIN 3 trial, with results expected in Q3 2026.
An investor webcast regarding the approval was scheduled for July 7 at 4:30 pm EDT.
The TRUTAKNA TRU SUPPORT program offers insurance coverage assistance & financial support for eligible patients.
Contraindications include serious hypersensitivity to the drug, & warnings emphasize risks of infection & live vaccine administration.