Equillium, Inc. announced on April 24, 2025, that it received feedback from the U.S. Food and Drug Administration (FDA) regarding the regulatory pathway for itolizumab in acute graft-versus-host disease (aGVHD). The FDA declined to grant Breakthrough Therapy Designation for itolizumab.
The agency also did not support an Accelerated Approval pathway based on the topline data from the Phase 3 EQUATOR study. The FDA emphasized its focus on Day 29 outcomes, aligning with existing guidance for aGVHD treatments.
While the FDA indicated openness to evaluating other endpoints if independently validated, this feedback represents a significant hurdle for Equillium's plans for a rapid approval path. The company will need to re-evaluate its regulatory strategy for itolizumab.
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