Difference between revisions of "Ropeginterferon alfa-2b (Besremi)"
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==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2019-02-15: Initial authorization | *2019-02-15: Initial authorization | ||
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+ | ==History of changes in PMDA indication== | ||
+ | *2023-03-27: Initial approval | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' AOP2014 | *'''Code name:''' AOP2014 | ||
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[[Category:EMA approved in 2019]] | [[Category:EMA approved in 2019]] | ||
[[Category:FDA approved in 2021]] | [[Category:FDA approved in 2021]] | ||
+ | [[Category:PMDA approved in 2023]] |
Revision as of 16:51, 15 June 2023
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
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: AOP2014
- Generic name: ropeginterferon alfa-2b-njft
- Brand name: Besremi