NYPOZI
NYPOZI (filgrastim-txid) is a leukocyte growth factor used to manage neutropenia and reduce the risk of associated infections in several patient populations. It is indicated for patients with nonmyeloid malignancies receiving myelosuppressive or myeloablative chemotherapy, as well as those with acute myeloid leukemia or chronic forms of neutropenia. Additionally, the drug is used to mobilize hematopoietic progenitor cells for collection and to increase survival following acute exposure to myelosuppressive doses of radiation.
How NYPOZI Works
NYPOZI functions as a colony-stimulating factor that binds to specific cell surface receptors on hematopoietic cells. This binding stimulates the proliferation, differentiation, and activation of neutrophil progenitors within the bone marrow. By mimicking endogenous G-CSF, the drug specifically regulates the production of neutrophils and enhances their functional abilities, such as phagocytosis and antibody-dependent killing, with minimal effect on other cell lineages.
Details
- Status
- Prescription
- First Approved
- 2024-06-28
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NYPOZI Approval History
What NYPOZI Treats
7 indicationsNYPOZI is approved for 7 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Febrile Neutropenia
- Acute Myeloid Leukemia
- Neutropenia
- Congenital Neutropenia
- Cyclic Neutropenia
- Idiopathic Neutropenia
- Acute Radiation Syndrome
NYPOZI is a lower-cost alternative to Neupogen with no clinically meaningful differences. Requires prescriber approval to substitute.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NYPOZI FDA Label Details
ProIndications & Usage
FDA Label (PDF)NYPOZI is a leukocyte growth factor 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 malignancie...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.