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Emapalumab - Swedish Orphan Biovitrum

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Drug Profile

Emapalumab - Swedish Orphan Biovitrum

Alternative Names: Emapalumab-Izsg; Gamifant; NI-0501

Latest Information Update: 04 Apr 2025

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At a glance

  • Originator NovImmune SA
  • Developer Institut Merieux; Swedish Orphan Biovitrum
  • Class Monoclonal antibodies
  • Mechanism of Action Interferon gamma inhibitors
  • Orphan Drug Status

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

    Yes - Haemophagocytic lymphohistiocytosis; Transplant rejection
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Haemophagocytic lymphohistiocytosis
  • Phase II/III COVID 2019 infections
  • Phase II Sepsis; Transplant rejection
  • No development reported Unspecified

Most Recent Events

  • 22 Mar 2025 Phase-II clinical trials in Sepsis in Greece (IV)
  • 19 Mar 2025 NovImmune-SA and Swedish Orphan Biovitrum enters a research collaboration for a phase II trial for Emapalumab
  • 27 Feb 2025 FDA assigns PDUFA action date of 27/06/2025 for Emapalumab for Haemophagocytic lymphohistiocytosis

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