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Eltrombopag - Novartis

Drug Profile

Eltrombopag - Novartis

Alternative Names: 497115; Eltrombopag olamine; Promacta; Revolade; SB-497115; SB-497115-GR

Latest Information Update: 31 Jul 2019

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At a glance

  • Originator Ligand Pharmaceuticals
  • Developer French Innovative Leukemia Organisation; GlaxoSmithKline; Novartis; Technische Universitat Dresden; US Department of Health and Human Services
  • Class Antianaemics; Antineoplastics; Benzoates; Hydrazines; Pyrazoles; Small molecules
  • Mechanism of Action Thrombopoietin receptor agonists
  • Orphan Drug Status

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

    Yes - Idiopathic thrombocytopenic purpura
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Aplastic anaemia; Idiopathic thrombocytopenic purpura; Thrombocytopenia
  • Phase II Acute myeloid leukaemia
  • Research Radiation injuries
  • Discontinued Myelodysplastic syndromes

Most Recent Events

  • 26 Jul 2019 Novartis requests a re-examination of the CHMP negative opinion on the approval of eltrombopag for Aplastic anaemia in European Union
  • 27 Jun 2019 The EMA issues negative opinion regarding change of existing marketing authorisation in Aplastic anaemia (on account of inability to draw favourable inference from a clinical study)
  • 19 Jun 2019 Novartis Pharmaceuticals plans a phase II trial for Aplastic anemia in China (NCT03988608)
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