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Emapalumab - Swedish Orphan Biovitrum

Drug Profile

Emapalumab - Swedish Orphan Biovitrum

Alternative Names: emapalumab-lzsg; Gamifant; NI-0501

Latest Information Update: 30 May 2024

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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 Transplant rejection
  • No development reported Unspecified

Most Recent Events

  • 24 May 2024 Emapalumab - Swedish Orphan Biovitrum receives Fast Track designation for Haemophagocytic lymphohistiocytosis in USA (IV, Infusion)
  • 28 Feb 2024 No recent reports of development identified for phase-I development in Unspecified(In volunteers) in Japan (IV, Infusion)
  • 31 Dec 2023 Launched for Haemophagocytic lymphohistiocytosis in United Arab Emirates (IV) prior to December 2023
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