Ropeginterferon alfa-2b (Besremi)

General information

Class/mechanism per NCI Drug Dictionary: A long-acting formulation of recombinant interferon alpha subtype 2b (IFN-a2b) protein, in which IFN-a2b is coupled, via proline, to polyethylene glycol (PEG), with antiviral, immunomodulating and antineoplastic activities. Upon subcutaneous administration, IFN-a2b binds to specific interferon cell-surface receptors. This activates interferon-mediated signal transduction pathways and induces the transcription and translation of genes with interferon-specific response elements (ISREs); the protein products mediate antiviral, antiproliferative, anticancer, and immune-modulating effects. The PEG moiety inhibits proteolytic breakdown and clearance of IFN-a2b, which prolongs its half-life, extends the duration of its therapeutic effects and allows less frequent dosing. The proline linker facilitates the synthesis of a predominant (90%) positional isomer which allows for further increases in stability and a longer half-life than previous PEG conjugates.
Route: SC
Extravasation: n/a

Diseases for which it is used

• Polycythemia vera

History of changes in FDA indication

• 2021-11-12: Initial approval for adults with polycythemia vera. (Based on PEGINVERA)

History of changes in EMA indication

• 2019-02-15: Initial authorization

History of changes in PMDA indication

• 2023-03-27: Initial approval

Also known as

• Code name: AOP-2014
• Generic name: ropeginterferon alfa-2b-njft
• Brand name: Besremi