Zenas BioPharma Announces Submission of Biologics License Application (BLA) to U.S. FDA for Obexelimab in IgG4-RD
Zenas BioPharma submitted a Biologics License Application (BLA) to the FDA for obexelimab, its lead candidate for treating IgG4-Related Disease (IgG4-RD). The submission is supported by the Phase 3 INDIGO trial, which met its primary endpoint with a 56% reduction in flare risk versus placebo (HR 0.44, p=0.0005) and all four key secondary endpoints.
Key figures
- Drug Name
- obexelimab
- Phase Of Trial
- Phase 3
- P value
- 0.0005
- Hazard ratio
- 0.44
- Total trials
- 8
- Trial duration weeks
- 52
- Total subjects evaluated
- 383
- Primary endpoint reduction
- 56%
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