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Equillium Seeks Accelerated Approval For GVHD Drug Despite Primary Endpoint Miss

 
• By Alaric DeArment

The biotech is banking on itolizumab’s longer-term efficacy as well as unmet need in frontline acute graft-versus-host disease as it prepares to meet with the FDA.

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Equillium is hoping that unmet medical need and long-term efficacy will persuade the US Food and Drug Administration to approve itolizumab for acute graft-versus-host disease (aGVHD) despite its Phase III trial failing to meet its primary endpoint and a key secondary endpoint.

Key Takeaways
  • Equillium said the Phase III EQUATOR trial missed the primary and a key secondary endpoint in first-line treatment of acute GVHD while showing longer-term efficacy.

The La Jolla, CA-based biotech said 27 March that the Phase III EQUATOR study comparing itolizumab against placebo did not...

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