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Nyvepria FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 27, 2020.

FDA Approved: Yes (First approved June 10, 2020)
Brand name: Nyvepria
Generic name: pegfilgrastim-apgf
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Neutropenia Associated with Chemotherapy

Nyvepria (pegfilgrastim-apgf) is a PEGylated growth colony-stimulating factor biosimilar to Neulasta (pegfilgrastim) used to reduce the incidence of febrile neutropenia in patients treated with chemotherapy.

  • Nyvepria is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
  • Nyvepria was approved as a biosimilar based on data demonstrating that it is highly similar to the FDA-approved biological reference product containing pegfilgrastim, and that there are no clinically meaningful differences between the biosimilar product and the reference product.
  • Nyvepria is administered subcutaneously via a single-dose prefilled syringe.
  • Patients should be made aware of the following risks associated with the use of Nyvepria: splenic rupture, acute respiratory distress syndrome, serious allergic reactions, sickle cell crises, and glomerulonephritis.
  • Common adverse reactions include bone pain and pain in extremities.
  • Nyvepria is the fourth FDA-approved pegfilgrastim biosimilar, after the approvals of Ziextenzo (pegfilgrastim-bmez ), Udenyca (pegfilgrastim-cbqv) and Fulphila (pegfilgrastim-jmdb).

Development timeline for Nyvepria

Jun 11, 2020Approval FDA Approves Nyvepria (pegfilgrastim-apgf), a Biosimilar to Neulasta

Further information

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