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Bivalirudin - The Medicines Company

Drug Profile

Bivalirudin - The Medicines Company

Alternative Names: Angiomax; Angiomax RTU; Angiox; BG-8967; Hirulog-1

Latest Information Update: 31 Jul 2019

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At a glance

  • Originator Biogen Idec
  • Developer The Medicines Company
  • Class Antithrombotics; Hirudins; Ischaemic heart disorder therapies; Peptide fragments; Recombinant proteins
  • Mechanism of Action Thrombin inhibitors
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Acute coronary syndromes; Heparin-induced thrombocytopenia and thrombosis syndrome; Thrombosis; Unstable angina pectoris
  • Phase III Myocardial infarction

Most Recent Events

  • 25 Jul 2019 The US FDA approves MAIA Pharmaceutical's Bivalirudin ready-to-use injection (ANGIOMAX RTU) for Thrombosis prevention (in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome)
  • 24 Jun 2018 Biomarkers information updated
  • 22 Jan 2018 The US FDA approves Bivalirudin in 0.9% Sodium Chloride Injection for Thrombosis prevention (in patients undergoing peripheral endovascular interventions)
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