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Biopharmaceutical Drug Development: A Case History

Filgrastim (NEUPOGEN, GRAN)
  • Mary Ann Foote
  • Thomas Boone
Chapter

Abstract

In the 1980s, human and murine forms of many hematopoietic colony stimulating factors were cloned. One factor that was purified, cloned, and produced in commercial quantities was granulocyte colony-stimulating factor (G-CSF, Filgrastim), a protein that acts on the neutrophil lineage. Neutrophils are the body’s major defence against infections. The initial licensing indication for Filgrastim was the amelioration of chemotherapy-induced neutropenia. It has been approved in more than 75 countries for a variety of uses, including aplastic anaemia, severe chronic neutropenia, and the mobilisation of peripheral blood progenitor cells for transplantation. Filgrastim has an excellent safety profile with the only common side effect of administration reported being mild to moderate bone pain. Current issues being investigated include evaluation of the cost benefit of Filgrastim in various clinical settings and impact on survival in dose-intensive chemotherapy with Filgrastim given as an adjunct treatment.

Key words

Filgrastim r-metHuG-CSF colony-stimulating factors haematopoiesis neutrophils Amgen Inc. 

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Copyright information

© Springer Science+Business Media Dordrecht 1999

Authors and Affiliations

  • Mary Ann Foote
    • 1
  • Thomas Boone
    • 1
  1. 1.Amgen Inc.USA

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