BESREMI (ropeginterferon alfa-2b-njft)
BESREMI is indicated for the treatment of Polycythemia Vera.
How BESREMI Works
BESREMI works by binding to the interferon alfa receptor (IFNAR), a transmembrane receptor located in the bone marrow. This binding triggers a signaling cascade that activates Janus kinase 1 (JAK1), tyrosine kinase 2 (TYK2), and activator of transcription (STAT) proteins. The activated STAT proteins then move into the cell nucleus to control gene-expression programs that produce various cellular effects. While these actions are known to occur, the exact mechanisms responsible for the drug's therapeutic effects in polycythemia vera are not fully elucidated.
Details
- Status
- Prescription
- First Approved
- 2021-11-12
- Patent Cliff
- 2028
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
BESREMI Approval History
What BESREMI Treats
1 indicationsBESREMI is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Polycythemia Vera
BESREMI Boxed Warning
These highlights do not include all the information needed to use BESREMi safely and effectively. See full prescribing information for BESREMi. BESREMi (ropeginterferon alfa-2b-njft) injection, for subcutaneous use Initial U.S. Approval: 2021 WARNING: RISK OF SERIOUS DISORDERS Risk of Serious Disorders: Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clin...
These highlights do not include all the information needed to use BESREMi safely and effectively. See full prescribing information for BESREMi. BESREMi (ropeginterferon alfa-2b-njft) injection, for subcutaneous use Initial U.S. Approval: 2021 WARNING: RISK OF SERIOUS DISORDERS Risk of Serious Disorders: Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy [ see Warnings and Precautions (5.1 , 5,2 , 5.3 , 5.4) and Adverse Reactions (6.1) ]. WARNING: RISK OF SERIOUS DISORDERS See full prescribing information for complete boxed warning . Risk of Serious Disorders: Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders.
BESREMI Target & Pathway
ProTarget
A member of the JAK family involved in signaling for interferons and several interleukins. JAK1 inhibition is effective in rheumatoid arthritis, atopic dermatitis, and other inflammatory conditions by blocking multiple cytokine pathways.
BESREMI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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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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.
BESREMI FDA Label Details
Indications & Usage
FDA Label (PDF)BESREMI is indicated for the treatment of Polycythemia Vera.
These highlights do not include all the information needed to use BESREMi safely and effectively. See full prescribing information for BESREMi. BESREMi (ropeginterferon alfa-2b-njft) injection, for subcutaneous use Initial U.S. Approval: 2021 WARNING: RISK OF SERIOUS DISORDERS Risk of Serious Disord...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.