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Ropeginterferon alfa-2b

Generic Name
Ropeginterferon alfa-2b
Brand Names
Besremi
Drug Type
Biotech
CAS Number
1335098-50-4
Unique Ingredient Identifier
981TME683S

Overview

Polycythemia vera (PV) is the most common Philadelphia chromosome-negative myeloproliferative neoplasm (MPN), characterized by increased hematocrit and platelet/leukocyte counts, an increased risk for hemorrhage and thromboembolic events, and a long-term propensity for myelofibrosis and leukemia. Interferon alfa-2b has been used for decades to treat PV but requires frequent dosing and is not tolerated by all patients. Ropeginterferon alfa-2b is a next-generation mono-pegylated type I interferon produced from proline-IFN-α-2b in Escherichia coli that has high tolerability and a long half-life. Ropeginterferon alfa-2b has shown efficacy in PV in in vitro and in vivo models and clinical trials. Ropeginterferon alfa-2b was approved by the FDA on November 12, 2021, and is currently marketed under the trademark BESREMi by PharmaEssentia Corporation.

Background

Polycythemia vera (PV) is the most common Philadelphia chromosome-negative myeloproliferative neoplasm (MPN), characterized by increased hematocrit and platelet/leukocyte counts, an increased risk for hemorrhage and thromboembolic events, and a long-term propensity for myelofibrosis and leukemia. Interferon alfa-2b has been used for decades to treat PV but requires frequent dosing and is not tolerated by all patients. Ropeginterferon alfa-2b is a next-generation mono-pegylated type I interferon produced from proline-IFN-α-2b in Escherichia coli that has high tolerability and a long half-life. Ropeginterferon alfa-2b has shown efficacy in PV in in vitro and in vivo models and clinical trials. Ropeginterferon alfa-2b was approved by the FDA on November 12, 2021, and is currently marketed under the trademark BESREMi by PharmaEssentia Corporation.

Indication

Ropeginterferon alfa-2b is indicated for the treatment of adult patients with polycythemia vera.

Associated Conditions

  • Polycythemia Vera (PV)

Clinical Trials

FDA Approved Products

BESREMi
Manufacturer:PharmaEssentia USA
Route:SUBCUTANEOUS
Strength:500 ug in 1 mL
Approved: 2024/01/12
NDC:73536-500

Singapore Approved Products

Besremi Solution for Injection in Prefilled Syringe 500 micrograms/mL
Manufacturer:PharmaEssentia Corporation, Taichung Plant
Form:INJECTION, SOLUTION
Strength:500 µg/mL
Online:Yes
Approved: 2024/05/29
Approval:SIN17014P

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