BESREMi lands in Big 5 Hospitals in Korea

New drug for polycythemia vera (PV) 

Passes drug committees of SMC, SNUH, St. Mary’s Hospital, Severance Hospital, and AMC

Confirms efficacy in patients resistant or intolerant  to hydroxyurea

BESREMi, a new drug for polycythemia vera, has been approved for prescription at tertiary hospitals in Korea.

 

According to the industry sources, PharmaEssentia Korea's BESREMi (ropeginterferon alfa-2b, a treatment for polycythemia vera, has recently passed the Drug Committees (DCs) of the Big 5 medical institutions in Korea, including Samsung Medical Center, Seoul National University Hospital, Seoul St.

 

Mary's Hospital, Asan Medical Center, and Severance Hospital.

 

As the drug’s reimbursement review is underway, the drug’s reimbursement listing is expected to quickly lead to actual prescriptions.

 

Polycythemia vera is a rare blood disorder where a somatic cell mutation in the bone marrow abnormally activates bone marrow function and produces excessive red blood cells.

 

It has a short survival period and is so fatal that 10~15% of patients with polycythemia vera develop myelofibrosis or leukemia within 10 years.

 

Although hydroxyurea had been used as the standard of care, it was difficult to fundamentally cure the disease with hydroxyurea, and patients who could not be treated with hydroxyurea had limitations as there were practically no drugs available for them in Korea’s domestic reimbursement environment.

 

BESREMi, an interferon treatment that selectively removes JAK2 mutations that cause polycythemia vera.

 

In Korea, the drug received approval in October 2020 to treat low-risk and high-risk patients with polycythemia vera without symptomatic splenomegaly.

 

The drug demonstrated its potential as a radical treatment for polycythemia vera in patients who had not received cytoreduction therapy or received less than 3 years of treatment with hydroxyurea.

 

Therefore, whether the only interferon treatment option approved for polycythemia vera will be born in Korea is receiving attention.

 

BESREMi demonstrated its efficacy and safety in the Phase III PROUD/CONTINUATION-PV trial that was conducted on polycythemia vera patients.

 

Trial results showed that 53% of the patients in the Besremi arm achieved a complete hematological response, an improvement compared with the hydroxyurea patient arm (38%).

 

The hematologic and molecular response rates at 72 months were also high, at 80.4% and 65.3% in low-risk and high-risk patients, respectively.

 

Regardless of their risk, patients treated with Besremi did not require phlebotomy even 6 years after administration.

 

Besremi is recommended as a first-line or second-line treatment for polycythemia vera in the National Comprehensive Cancer Network (NCCN) and European Leukemia Network (ELN) guidelines, regardless of previous treatment experience.