Ropeginterferon alfa-2b

Ropeginterferon alfa-2b, sold under the brand name Besremi, is a medication used to treat polycythemia vera.[1][2][3][4] It is an interferon.[1][3] It is given by injection.[1][3]

Ropeginterferon alfa-2b
Clinical data
Trade namesBesremi
Other namesAOP2014, ropeginterferon alfa-2b-njft
AHFS/Drugs.comMonograph
MedlinePlusa622019
License data
Pregnancy
category
  • Contraindicated
Routes of
administration		Subcutaneous
Drug classInterferon
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG

The most common side effects include low levels of white blood cells and platelets (blood components that help the blood to clot), muscle and joint pain, tiredness, flu-like symptoms and increased blood levels of gamma-glutamyl transferase (a sign of liver problems).[3] Ropeginterferon alfa-2b can cause liver enzyme elevations, low levels of white blood cells, low levels of platelets, joint pain, fatigue, itching, upper airway infection, muscle pain and flu-like illness.[2] Side effects may also include urinary tract infection, depression and transient ischemic attacks (stroke-like attacks).[2]

It was approved for medical use in the European Union in February 2019,[3] and in the United States in November 2021.[2][5] Ropeginterferon alfa-2b is the first medication approved by the US Food and Drug Administration (FDA) to treat polycythemia vera that people can take regardless of their treatment history, and the first interferon therapy specifically approved for polycythemia vera.[2] The FDA considers it to be a first-in-class medication.[6]

Medical uses

In the European Union, ropeginterferon alfa-2b is indicated as monotherapy in adults for the treatment of polycythemia vera without symptomatic splenomegaly.[3] In the United States it is indicated for the treatment of polycythemia vera.[1][2][5]

History

The effectiveness and safety of ropeginterferon alfa-2b were evaluated in a multicenter, single-arm trial that lasted 7.5 years.[2] In this trial, 51 adults with polycythemia vera received ropeginterferon alfa-2b for an average of about five years.[2] The effectiveness of ropeginterferon alfa-2b was assessed by looking at how many participants achieved complete hematological response, which meant that participants had a red blood cell volume of less than 45% without a recent phlebotomy, normal white cell counts and platelet counts, a normal spleen size, and no blood clots.[2] Overall, 61% of participants had a complete hematological response.[2] Participants received the highest administered dose tolerated every two weeks subcutaneously.[7] The starting dose was lower for participants who were transitioning from hydroxyurea.[7] The trial was conducted at six sites exclusively in Austria.[7] The safety of ropeginterferon alfa-2b was based primarily on findings from the efficacy study in 51 participants.[7] Two additional studies served as supportive safety data;[7] therefore, the number of participants representing efficacy findings may differ from the number of participants representing safety findings due to different pools of study participants analyzed for efficacy and safety.[7]

The US Food and Drug Administration (FDA) granted the application for ropeginterferon alfa-2b orphan drug designation[6] and granted the approval of Besremi to PharmaEssentia Corporation.[2]

References
  1. "Besremi- ropeginterferon alfa-2b injection". DailyMed. Archived from the original on 19 December 2021. Retrieved 19 December 2021.
  2. "FDA Approves Treatment for Rare Blood Disease". U.S. Food and Drug Administration (FDA) (Press release). 12 November 2021. Retrieved 12 November 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  3. "Besremi EPAR". European Medicines Agency (EMA). 12 December 2018. Archived from the original on 11 July 2022. Retrieved 14 November 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. Wagner SM, Melchardt T, Greil R (March 2020). "Ropeginterferon alfa-2b for the treatment of patients with polycythemia vera". Drugs of Today. Barcelona, Spain. 56 (3): 195–202. doi:10.1358/dot.2020.56.3.3107706. PMID 32282866. S2CID 215758794.
  5. "U.S. FDA Approves Besremi (ropeginterferon alfa-2b-njft) as the Only Interferon for Adults With Polycythemia Vera" (Press release). PharmaEssentia. 12 November 2021. Retrieved 14 November 2021 – via Business Wire.
  6. Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  7. "Drug Trials Snapshots: Besremi". U.S. Food and Drug Administration. 12 November 2021. Archived from the original on 8 September 2023. Retrieved 10 September 2023. Public Domain This article incorporates text from this source, which is in the public domain.


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