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Remestemcel-L - Mesoblast

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Drug Profile

Remestemcel-L - Mesoblast

Alternative Names: hMSC - Mesoblast; human mesenchymal stem cells - Mesoblast; JR-0301; JR-031; JR-031 HIE; JR-031EB; MSC-100; MSC-100-IV; OTI-010; OTI-020; OTI-021; Prochymal; Provacel; RYONCIL; Stromagen; TEMCELL HS Inj.

Latest Information Update: 02 Aug 2024

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At a glance

  • Originator Osiris Therapeutics
  • Developer Cleveland Clinic; JCR Pharmaceuticals; Mesoblast; Osaka University; Osiris Therapeutics
  • Class Mesenchymal stem cell therapies
  • Mechanism of Action Cell replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Graft-versus-host disease; Type 1 diabetes mellitus; Epidermolysis bullosa
  • New Molecular Entity No

Highest Development Phases

  • Marketed Graft-versus-host disease
  • Preregistration Epidermolysis bullosa
  • Phase III Back pain; Crohn's disease; Myocardial infarction; SARS-CoV-2 acute respiratory disease
  • Phase I/II Brain hypoxia-ischaemia; Ulcerative colitis
  • Discontinued Acute radiation syndrome; Chronic obstructive pulmonary disease; Type 1 diabetes mellitus

Most Recent Events

  • 31 Jul 2024 FDA assigns PDUFA action date of 7/1/2025 for remestemcel-L for Graft-versus-host disease (In Children, Treatment-experienced)
  • 30 Jul 2024 Mesoblast plans to launch remestemcel-L for Graft versus Host Disease
  • 23 Jul 2024 US FDA accepts resubmitted BLA for Remestemcel-L for steroid-refractory acute graft versus host disease (In children) for review

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