Pegfilgrastim
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Pegfilgrastim, sold under the brand name Neulasta among others, is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim.[1] It serves to stimulate the production of white blood cells (neutrophils).[1][2] Pegfilgrastim was developed by Amgen.[3]
Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.[4]
Pegfilgrastim has a human half-life of 15 to 80 hours, much longer than the parent filgrastim (3–4 hours).[5][4]
Pegfilgrastim was approved for medical use in the United States in January 2002, in the European Union in August 2002, and in Australia in September 2002.[3][6][7][8][9] It is on the World Health Organization's List of Essential Medicines.[10]
Medical uses
Pegfilgrastim is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in people with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia; and to increase survival in people acutely exposed to myelosuppressive doses of radiation (hematopoietic subsyndrome of acute radiation syndrome).[1][11][12]
Society and culture
Legal status
In January 2025, the Committee for Medicinal Products for Human Use CHMP of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Dyrupeg, intended to shorten the duration of neutropenia and help prevent febrile neutropenia after cytotoxic chemotherapy.[13] The applicant for this medicinal product is CuraTeQ Biologics s.r.o.[13] Dyrupeg is a biosimilar medicinal product that is highly similar to the reference product Neulasta, which was authorized in the EU in August 2002.[13] Dyrupeg was authorized for medical use in the European Union in March 2025.[13][14]
In June 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vivlipeg, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.[15] The applicant for this medicinal product is Biosimilar Collaborations Ireland Limited.[15] Vivlipeg is a biosimilar medicinal product that is highly similar to Neulasta.[15]
References
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- ↑ a b c Cite error: Script error: No such module "Namespace detect".Script error: No such module "Namespace detect".
- ↑ Walsh, G, Spada, S. "Epogen/Procrit" in: Directory of approved biopharmaceutical products. CRC Press, 2005, pp. 136–37.
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- ↑ a b c d Script error: No such module "citation/CS1". Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
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- ↑ a b c Script error: No such module "citation/CS1". Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
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