Besremi for Polycythemia Vera Approved in Korea

When drug developers receive marketing approval in different countries, they expand medication access and allow patients across the globe to have better treatment. According to Korea Biomedical Review, Korea recently approved Besremi (ropeginterferon alfa-2b) for patients with polycythemia vera (PCV) without symptomatic splenomegaly (spleen enlargement). The therapy can treat both high and low-risk patients.

Besremi

According to Clinical Trials Arena, Besremi is:

a long-acting, mono-pegylated proline interferon developed using PharmaEssentia’s novel pegylation technology platform. It has exhibited improved pharmacokinetic properties in clinical studies, including increased tolerability and convenience.

The therapy is given via an injectable pen every 2 to 4 weeks. Compared to the current standards-of-care, which have a much shorter dosing cycle, Besremi offers a more accessible, effective, and less invasive therapeutic option for patients. The treatment was approved following data submission from the Phase 3 PROUD/CONTINUATION-PV clinical trial. During the trial, researchers evaluated the therapy’s efficacy, tolerability, and safety for patients with polycythemia vera. Findings included:

  • Over 50% of the patients treated with Besremi significantly reduced the JAK2 V617F allele burden.
  • Besremi therapy showed durable and sustained responses within patients.
  • Altogether, the therapy was found to be relatively safe and well-tolerated. However, some side effects did occur. These include fatigue, thrombocytopenia (low platelet count), leukopenia (low leukocyte count), muscle and joint pain, and increased GGT levels.

Polycythemia Vera (PCV)

Polycythemia vera (PCV) is a rare and slow-growing blood cancer which begins in the bone marrow. JAK2 gene mutations cause polycythemia vera. Normally, this gene plays a role in cell production and regulation within the bone marrow. The mutations cause the bone marrow to overproduce red blood cells, prompting the blood to become overly thick. This gene mutation is thought to occur spontaneously, and is not inherited from family. Because of how slow polycythemia vera develops, patients may not experience symptoms for years. When symptoms appear, these include:

  • Headache
  • Dizziness
  • Itchiness which worsens after warm water exposure
  • Abdominal pain
  • Enlarged spleen
  • Blood clots
  • Double vision
  • Excessive sweating
  • Joint pain, especially in the big toes
  • Shortness of breath which worsens when lying down
  • General malaise and body weakness
  • Stroke
  • Heart attack
Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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