Damoctocog alfa pegol - Bayer HealthCare Pharmaceuticals

Drug Profile

Damoctocog alfa pegol - Bayer HealthCare Pharmaceuticals

Alternative Names: BAY-949027; Damoctocog alfa pegol; peg rFVIII; PEG rFVIII mutein; PEGylated B-Domain-Delted Recombinant rFVIII; PEGylated BDD-rFVIII; rFVIII glycopegylated

Latest Information Update: 04 Jan 2018

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At a glance

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

  • Preregistration Haemophilia A
  • Phase II Haemorrhage

Most Recent Events

  • 09 Dec 2017 Pharmacokinetics data from preclinical studies of the PEG moiety presented at the 59th Annual Meeting and Exposition of the American Society of Hematology (ASH-Hem-2017)
  • 30 Nov 2017 Phase-I clinical trials in Haemophilia A in Bulgaria (IV) (NCT03364998)
  • 30 Oct 2017 US FDA accepts BLA for damoctocog alfa pegol for Haemophilia A (Treatment-experienced) for review
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