Bivalirudin

Drug Profile

Bivalirudin

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

Latest Information Update: 25 Mar 2017

Price : $50

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.

    No
  • 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 Acute coronary syndromes; Heparin-induced thrombocytopenia and thrombosis syndrome; Thrombosis; Unstable angina pectoris

Most Recent Events

  • 06 Mar 2017 SciClone anticipates approval of bivalirudin for Heparin-induced thrombocytopenia and thrombosis syndrome and Unstable angina pectoris in China in late 2017 or early 2018 (IV)
  • 06 Feb 2017 Bivalirudin is still under Preregistration for Heparin-induced thrombocytopenia and thrombosis syndrome and Unstable angina pectoris in China (IV)
  • 22 Nov 2016 Efficacy data from the phase III BRAVO-2/3 trial in Thrombosis prevention (in patients undergoing transaortic valve replacement) presented at the Annual Congress of the European Society of Cardiology (ESC-Card-2016)
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