Overview
- The FDA set a Prescription Drug User Fee Act target action date of July 7, 2026.
- The application was submitted under the Accelerated Approval Program using proteinuria reduction as a surrogate endpoint.
- A prespecified ORIGIN 3 interim analysis met its primary endpoint, with a 46% drop from baseline in 24-hour UPCR and a 42% reduction versus placebo at week 36.
- Atacicept is designed for once-weekly, at-home subcutaneous self-injection that inhibits BAFF and APRIL to modulate pathogenic B-cell activity.
- Novartis' iptacopan reported Phase 3 results showing slower disease progression measured by eGFR decline, underscoring a competitive late-stage landscape.