Damoctocog alfa pegol - Bayer HealthCare Pharmaceuticals

Drug Profile

Damoctocog alfa pegol - Bayer HealthCare Pharmaceuticals

Alternative Names: Antihemophilic factor [recombinant] PEGylated-aucl; BAY-949027; Damoctocog alfa pegol; Jivi; peg rFVIII; PEG rFVIII mutein; PEGylated B-Domain-Delted Recombinant rFVIII; PEGylated BDD-rFVIII; rFVIII glycopegylated

Latest Information Update: 25 Sep 2018

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At a glance

  • Originator Bayer HealthCare Pharmaceuticals
  • Class Antihaemorrhagics; Blood coagulation factors; Polyethylene glycols; Recombinant proteins
  • Mechanism of Action Factor VIII replacements
  • 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

  • Registered Haemophilia A
  • Phase II Haemorrhage

Most Recent Events

  • 21 Sep 2018 Registered for Haemophilia A (In adolescents, Treatment-experienced, In adults) in Japan (IV)
  • 21 Sep 2018 The EMA's Committee for Medical Products for Human Use (CHMP) recommends approval of damoctocog alfa pegol for Haemophilia A (In adolescents, In adults, Treatment-experienced)
  • 30 Aug 2018 Registered for Haemophilia A (In adolescents, Treatment-experienced, In adults) in USA (IV) - First Global Approval
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