Emapalumab

Drug Profile

Emapalumab

Alternative Names: NI-0501

Latest Information Update: 16 Jul 2016

Price : $50

At a glance

  • Originator NovImmune SA
  • 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II/III Haemophagocytic lymphohistiocytosis

Most Recent Events

  • 16 Jul 2016 No recent reports of development identified for phase-I development in Haemophagocytic lymphohistiocytosis(In volunteers) in United Kingdom (IV, Infusion)
  • 06 Jun 2016 The EMA designates PRIME status to NI 0501 for the treatment of Haemophagocytic lymphohistiocytosis in European Union
  • 16 Mar 2016 NI 0501 receives Breakthrough Therapy status for Haemophagocytic lymphohistiocytosis in USA
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