Vera Therapeutics TRUTAKNA Receives FDA Accelerated Approval for IgAN
Vera Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted TRUTAKNA (atacicept-vymj) accelerated approval to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk for disease progression. TRUTAKNA is the first and only therapy that binds both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), addressing immunological drivers of IgAN. In the ORIGIN 3 trial, participants treated with TRUTAKNA achieved a 46% reduction from baseline in proteinuria, with a statistically significant 42% reduction compared to placebo at 36 weeks. The approval is based on reduction of proteinuria, with continued approval contingent upon verification of clinical benefit in the ongoing ORIGIN 3 trial.
Key Highlights
- TRUTAKNA (atacicept-vymj) received FDA accelerated approval for IgAN.
- First and only available therapy binding both BAFF and APRIL for IgAN.
- Achieved 46% reduction from baseline in proteinuria in ORIGIN 3 trial.
- Showed 42% reduction vs. placebo (p<0.0001) at 36 weeks.
- Dose is 150 mg injected subcutaneously once weekly via autoinjector.
- Most common adverse reactions were infections (32%) and local administration reactions (30%).
- Continued approval contingent on verification of clinical benefit in ongoing ORIGIN 3 trial.
- Investor webcast scheduled for July 7 at 4:30 pm EDT.
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