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Reported Friday, Vera Therapeutics Submits BLA To FDA For Atacicept After ORIGIN Phase 3 Interim Analysis Demonstrates 42% Proteinuria Reduction Vs Placebo

Author: Benzinga Newsdesk | November 10, 2025 04:40am
  • Atacicept received FDA Breakthrough Therapy Designation for the treatment of IgAN
  • ORIGIN Phase 3 trial met its primary endpoint at the prespecified interim analysis of proteinuria reduction with 46% reduction from baseline and 42% reduction vs placebo at week 36 (p<0.0001)
  • If approved, atacicept would be the first B cell modulator targeting both BAFF and APRIL for IgAN; potential FDA approval in 2026

Posted In: VERA


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