Romiplostim

Drug Profile

Romiplostim

Alternative Names: AMG-531; Nplate; Romiplate

Latest Information Update: 16 Jan 2017

Price : $50

At a glance

  • Originator Kirin-Amgen
  • Developer Amgen; Kirin-Amgen
  • Class Carrier proteins; Recombinant fusion proteins
  • Mechanism of Action Immunosuppressants; Thrombopoietin receptor agonists; Thrombopoietin stimulants
  • Orphan Drug Status

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

    Yes - Immune thrombocytopenic purpura
  • 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

  • Marketed Immune thrombocytopenic purpura
  • Phase II/III Aplastic anaemia
  • Phase II Thrombocytopenia
  • Discontinued Myelodysplastic syndromes

Most Recent Events

  • 03 Dec 2016 Interim adverse events and efficacy data from a phase II trial in Aplastic anaemia presented at the 58th Annual Meeting and Exposition of the American Society of Hematology (ASH-Hem - 2016)
  • 01 May 2016 Phase-II/III clinical trials in Aplastic anaemia (Treatment-resistant) in South Korea and Japan (SC) (NCT02773290)
  • 19 Apr 2016 Registered for Immune thrombocytopenic purpura in Venezuela, Peru, Lebanon, Egypt, Macau, Ecuador, Morocco, Guatemala, Brazil, South Africa, Kuwait, Colombia, Serbia (SC) before April 2016
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