FDA Approves Besremi (ropeginterferon alfa-2b-njft) for Treating Polycythemia Vera

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FDA Approves Besremi (ropeginterferon
alfa-2b-njft) for Treating Polycythemia Vera

On 12 November 2021, the US Food and Drug Administration (FDA) has approved
Besremi (ropeginterferon alfa-2b-njft), developed by Pharma Essentia, for the
treatment of polycythemia vera, a blood disorder that causes overproduction of red
blood cells. Besremi is the first FDA-approved drug for the treatment of
polycythemia vera that can be taken by patients regardless of treatment history, and it is
also the first interferon therapy specifically for polycythemia vera. Previously, Besremi has
been granted orphan drug designation by the FDA for this indication and was approved by
the European Medicines Agency (EMA) in 2019.

The approval follows an evaluation of the effectiveness and safety from a Phase 3 clinical
trial. Results showed that following 7.5 years of treatment with Besremi, 61% of
patients achieved complete hematological response and 80% of patients experienced a
hematological response. The most common treatment-related adverse reactions
(incidence >40%) were flu-like illness, arthralgia, fatigue, pruritus, nasopharyngitis and
musculoskeletal pain, and serious adverse reactions (incidence >4%) were urinary tract
infection, transient ischemic attack and depression.

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Polycythemia vera is a rare, chronic, fatal blood cancer caused by a mutation in stem cells
in the patient's bone marrow, thus resulting in the overproduction of blood cells, white
blood cells, and platelets.. This can create health risks including blood clots, stroke, and
myocardial infarction. Most cases are caused by the JAK2 V617F mutation. If not well
controlled with treatment, the disease can progress to secondary myelofibrosis and
malignancies, including acute myeloid leukemia.

Besremi is an innovative mono-pegylated, long-acting proline interferon. Benefiting
from its unique PEGylation technology, Besremi has a long activity duration in patients
with polycythemia vera, enabling dosing every two weeks or longer until hematologic
parameters are stable and allowing flexible dosing to help meet individual patient needs.
After one year of treatment, patients in complete hematologic response and stability have
the option to undergo Besremi treatment with dosing every four weeks.

The technique of covalently attaching polyethylene glycols (PEGs) to specific molecules is
known as PEGylation and is now a well-established method in the field of targeted drug

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delivery systems. PEGylation offers several distinct pharmacological advantages
over unmodified forms, including improved drug solubility, reduced dose frequency,
toxicity and renal clearance, extended circulating life, increased drug stability, enhanced
protection against proteolytic degradation, reduced immunogenicity and antigenicity, and
minimal loss of biological activity.

Significance of PEGylated therapeutics. Image source: reference [2]

PEG is biocompatible, lacks immunogenicity, antigenicity and toxicity, is soluble in water
and other organic solvents, is readily cleared from the body and has high mobility in
solution, making this the polymer of choice for bioconjugation. Biopharma PEG, as a
leading PEG derivatives supplier, provides high purity PEG derivatives for your
drug PEGylation.

[1] U.S. FDA Approves Besremi® (ropeginterferon alfa-2b-njft) as the Only Interferon for Adults With
Polycythemia Vera. Retrieved November 12, 2021,
from https://www.businesswire.com/news/home/20211112005909/en/
[2] Prajna Mishra, Bismita Nayak, R.K. Dey, PEGylation in anti-cancer therapy: An overview, Asian
Journal of Pharmaceutical Sciences, Volume 11, Issue 3, 2016, Pages 337-348, ISSN
1818-0876, https://doi.org/10.1016/j.ajps.2015.08.011.

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