NYVEPRIA (pegfilgrastim-apgf)
NYVEPRIA is a leukocyte growth factor indicated to decrease the incidence of infection, manifested as febrile neutropenia, in patients with non-myeloid malignancies. It is used in patients receiving myelosuppressive anti-cancer drugs that are associated with a clinically significant risk of febrile neutropenia. This medication is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
How NYVEPRIA Works
NYVEPRIA is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors. This binding stimulates the proliferation, differentiation, and commitment of these cells. Additionally, the drug promotes end cell functional activation to support the immune system during myelosuppressive treatment.
Details
- Status
- Prescription
- First Approved
- 2020-06-10
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NYVEPRIA Approval History
What NYVEPRIA Treats
2 indicationsNYVEPRIA is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Febrile Neutropenia
- Infection
NYVEPRIA is a lower-cost alternative to Neulasta with no clinically meaningful differences. Requires prescriber approval to substitute.
NYVEPRIA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
NYVEPRIA FDA Label Details
Indications & Usage
FDA Label (PDF)NYVEPRIA is indicated for the treatment of Febrile Neutropenia; Infection.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.