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Pegfilgrastim - Amgen/Kyowa Hakko Kirin

Drug Profile

Pegfilgrastim - Amgen/Kyowa Hakko Kirin

Alternative Names: Filgrastim SD01; G-Lasta; KRN125; Neulasta; Neulasta Onpro® Kit; Neulastim; PEG filgrastim; PEG G-CSF; PEG-rmetHuG-CSF; Pegylated filgrastim; R 1471; r-metHuG-CSF-SD-01; SD-01; SD/01

Latest Information Update: 04 Nov 2018

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At a glance

  • Originator Kirin-Amgen
  • Developer Amgen; Kyowa Hakko Kirin
  • Class Chemoprotectants; Granulocyte colony-stimulating factors; Polyethylene glycols; Recombinant proteins
  • Mechanism of Action Granulocyte stimulants; Haematopoiesis 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

  • Marketed Neutropenia; Radiation injuries
  • Phase II Breast cancer

Most Recent Events

  • 20 Nov 2018 Kyowa Hakko Kirin plans a phase II trial for Neutropenia in South Korea (KCT0002985)
  • 01 Jul 2018 Phase-II clinical trials in Breast cancer (Neoadjuvant therapy, Combination therapy, Second-line therapy or greater) in France (SC) (NCT03571633)
  • 28 Feb 2018 The Committee for Medicinal Products for Human Use (CHMP) adopts positive opinion recommending a label variation for Neulasta to include the Neulasta Onpro® Kit
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