Overview
- The application was filed under the FDA’s Accelerated Approval pathway for adults with IgA nephropathy.
- A prespecified ORIGIN 3 interim analysis met the primary endpoint at week 36 with a 46% reduction from baseline in proteinuria and a 42% reduction versus placebo (p<0.0001).
- Investigators report a safety profile to date that appears comparable to placebo across the ORIGIN program.
- The blinded Phase 3 trial continues to collect two-year eGFR outcomes, with confirmatory results expected in 2027.
- If approved, atacicept would be a once-weekly at-home autoinjector that targets BAFF and APRIL as a potential first-in-class option.