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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/02 | Not Applicable | Recruiting | |||
2024/07/17 | N/A | Recruiting | FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS | ||
2024/06/21 | Phase 3 | Not yet recruiting | PharmaEssentia | ||
2024/03/04 | Phase 4 | Not yet recruiting | PharmaEssentia | ||
2023/08/21 | Phase 3 | Completed | PharmaEssentia Japan K.K. | ||
2023/04/11 | Phase 2 | Not yet recruiting | |||
2022/08/10 | Not Applicable | Recruiting | |||
2022/08/03 | Phase 2 | Active, not recruiting | PharmaEssentia | ||
2022/07/20 | Phase 2 | Not yet recruiting | |||
2021/08/04 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| PharmaEssentia USA | 73536-500 | SUBCUTANEOUS | 500 ug in 1 mL | 1/12/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/15/2019 | ||
Authorised | 2/15/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Besremi Solution for Injection in Prefilled Syringe 500 micrograms/mL | SIN17014P | INJECTION, SOLUTION | 500 µg/mL | 5/29/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ropeginterferon alfa-2b Injection | 药华医药股份有限公司 | 国药准字SC20240001 | 生物制品 | 注射剂 | 6/28/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||