Difference between revisions of "Ropeginterferon alfa-2b (Besremi)"

Latest revision as of 20:19, 27 June 2024

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

@@ Line 1: / Line 1: @@
 ==General information==
-Class/mechanism per [http://www.cancer.gov/publications/dictionaries/cancer-drug?CdrID=753252 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.
+Class/mechanism per [https://www.cancer.gov/publications/dictionaries/cancer-drug?CdrID=753252 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.
 <br>Route: SC
 <br>Extravasation: n/a
-==Preliminary data==
+==Diseases for which it is used==
+*[[Polycythemia vera]]
-===[[Polycythemia vera]]===
+==History of changes in FDA indication==
-# '''PEGINVERA:''' Gisslinger H, Zagrijtschuk O, Buxhofer-Ausch V, Thaler J, Schloegl E, Gastl GA, Wolf D, Kralovics R, Gisslinger B, Strecker K, Egle A, Melchardt T, Burgstaller S, Willenbacher E, Schalling M, Them NC, Kadlecova P, Klade C, Greil R. Ropeginterferon alfa-2b, a novel IFNα-2b, induces high response rates with low toxicity in patients with polycythemia vera. Blood. 2015 Oct 8;126(15):1762-9. Epub 2015 Aug 10. [http://www.bloodjournal.org/content/126/15/1762.long link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4608390/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26261238 PubMed] NCT01193699
+*2021-11-12: Initial approval for adults with [[polycythemia vera]]. ''(Based on PEGINVERA)''
-# '''PROUD-PV:''' Gisslinger H, Klade C, Georgiev P, Krochmalczyk D, Gercheva-Kyuchukova L, Egyed M, Rossiev V, Dulicek P, Illes A, Pylypenko H, Sivcheva L, Mayer J, Yablokova V, Krejcy K, Grohmann-Izay B, Hasselbalch HC, Kralovics R, Kiladjian JJ; PROUD-PV Study Group. Ropeginterferon alfa-2b versus standard therapy for polycythaemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study. Lancet Haematol. 2020 Mar;7(3):e196-e208. Epub 2020 Jan 31. [https://doi.org/10.1016/s2352-3026(19)30236-4 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32014125 PubMed] EudraCT 2012-005259-18
+==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
+*'''Code name:''' AOP-2014
+*'''Generic name:''' ropeginterferon alfa-2b-njft
+*'''Brand name:''' Besremi
 [[Category:Drugs]]
 [[Category:Subcutaneous medications]]
+[[Category:Pegylated medications]]
-[[Category:Interferons]]
+[[Category:Interferon alfas]]
 [[Category:Polycythemia vera medications]]
-[[Category:Investigational drugs]]
+[[Category:EMA approved in 2019]]
+[[Category:FDA approved in 2021]]
+[[Category:PMDA approved in 2023]]