Nypozi FDA Approval History

Last updated by Judith Stewart, BPharm on July 8, 2024.

FDA Approved: Yes (First approved June 28, 2024)
Brand name: Nypozi
Generic name: filgrastim-txid
Dosage form: Injection
Company: Tanvex BioPharma USA, Inc.
Treatment for: Neutropenia, Neutropenia Associated with Chemotherapy, Neutropenia Associated with Radiation, Bone Marrow Transplantation, Peripheral Progenitor Cell Transplantation, Hematopoietic Syndrome of Acute Radiation Syndrome

Nypozi (filgrastim-txid) is a leukocyte growth factor biosimilar to Neupogen indicated for the treatment of neutropenia, neutropenia associated with chemotherapy, neutropenia associated with radiation, bone marrow transplantation, and peripheral progenitor cell transplantation.

• Nypozi is indicated to:
  - decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever;
  - reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML);
  - reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT);
  - mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis;
  - reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia; and
  - increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome).
• Nypozi is biosimilar to Neupogen and does not have an interchangeability designation.
• Nypozi is administered by subcutaneous injection or intravenous infusion.
• FDA approval of Nypozi was based on scientific evidence that demonstrated the product is highly similar to Neupogen, and that there were no clinically meaningful differences from Neupogen.
• Warnings and precautions associated with Nypozi include splenic rupture, acute respiratory distress syndrome, serious allergic reactions, sickle cell crises, glomerulonephritis, myelodysplastic syndrome and acute myeloid leukemia, and thrombocytopenia.
• Common adverse reactions:
  - in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs include pyrexia, pain, rash, cough, and dyspnea.
  - in patients with acute myeloid leukemia include pain, epistaxis and rash.
  - in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT include rash.
  - in patients undergoing peripheral blood progenitor cell mobilization and collection include bone pain, pyrexia and headache.
  - in patients with severe chronic neutropenia include pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia.
• Nypozi is the fourth FDA-approved Neupogen biosimilar, following the approvals of Releuko (filgrastim-ayow) in 2022, Nivestym (filgrastim-aafi) in 2018, and Zarxio (filgrastim-sndz) in 2015.

Development timeline for Nypozi

Further information

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