Express 61% of patients achieved complete remission!

▎The content team editor of WuXi AppTec recently, PharmaEssentia announced that the US FDA has approved the long-acting interferon Besremi (ropeginterferonα-2b-njft) to be marketed for the treatment of adult patients with polycythemia vera (PV)
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The press release stated that Besremi is the first interferon drug approved by the FDA to treat the disease
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 This approval is based on positive efficacy and safety data obtained in a phase 3 clinical trial
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The test results showed that after receiving Besremi treatment for 7.
5 years, 61% of patients with polycythemia vera achieved complete hematological remission, and 80% of patients had hematological responses
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The most common adverse reactions related to treatment (incidence rate>40%) are influenza-like illness, arthralgia, fatigue, pruritus, nasopharyngitis, and musculoskeletal pain.
Severe adverse reactions (incidence rate>4%) are urinary tract infection, transient Ischemic attack and depression
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Polycythemia vera is a rare, chronic and fatal blood cancer
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The pathogenic principle is that the stem cells in the patient's bone marrow undergo mutations, leading to excessive production of blood cells, white blood cells, and platelets, resulting in health risks, including blood clots, strokes and heart attacks
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Most cases are caused by the V617F mutation of JAK2
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Without good treatment and control, the disease can progress to secondary myelofibrosis and malignant tumors, including acute myeloid leukemia
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Besremi is an innovative monoformylated, long-acting interferon
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With its unique PEGylation technology, Besremi has a long active duration in patients with polycythemia vera, and can be administered once every two weeks or longer until the hematological parameters are stable, and flexible administration is allowed , Help to meet the individual needs of patients
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After one year of treatment, patients with complete hematological remission and stable hematology can choose to be treated with Besremi once every four weeks
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Previously, Besremi had obtained the FDA-approved orphan drug designation for the treatment of polycythemia vera, and was approved by the European Medicines Agency (EMA) in 2019
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Dr.
Ko-Chung Lin, co-founder and CEO of Yaohua Medicine, said: “We are extremely proud of our goal of bringing treatments like Besremi to patients with polycythemia vera
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These patients are more effective and resistant.
There is a significant unmet need for acceptable and durable treatments
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As we integrate this important treatment into clinical practice, we also continue to advance scientific research efforts to fully tap the full potential of innovative compounds
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"References:[ 1] US FDA Approves Besremi® (ropeginterferon alfa-2b-njft) as the Only Interferon for Adults With Polycythemia Vera.
Retrieved November 12, 2021, from https:// Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
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This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
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This article is not a treatment recommendation either
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If you need guidance on treatment plans, please go to a regular hospital for treatment
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