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Pegfilgrastim - Amgen/Kyowa Kirin

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Drug Profile

Pegfilgrastim - Amgen/Kyowa Kirin

Alternative Names: Filgrastim SD01; G-Lasta; KRN 125; 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: 05 Nov 2023

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At a glance

  • Originator Kirin-Amgen
  • Developer Amgen; Kyowa Kirin
  • Class Antineoplastics; Chemoprotectants; Granulocyte colony-stimulating factors; Polyethylene glycols; Radioprotectives; Recombinant proteins
  • Mechanism of Action Granulocyte colony stimulating factor replacements
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Chemotherapy induced febrile neutropenia; Radiation injuries; Stem cell mobilisation
  • Phase II Breast cancer; HER2 positive breast cancer

Most Recent Events

  • 31 Jul 2023 Kyowa Kirin applied for partial change of approved indication of Pegfilgrastim in Japan (Kyowa Kirin pipeline, August 2023)
  • 25 Oct 2022 Kyowa Kirin completes a phase II trial in Stem cell mobilization in Japan (NCT05007652)
  • 13 May 2022 Launched for Stem cell mobilisation in Japan (SC), prior to March 2022 (Kyowa Kirin's pipeline, May 2022)

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