FDA renews approval of the first interferon for the treatment of polycythemia vera

On November 12, 2021, the US Food and Drug Administration (FDA) approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adult patients with polycythemia vera (a blood disease that causes excessive red blood cell production)
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ropeginterferon alfa-2b-njft is the first drug approved by the FDA to treat patients with polycythemia vera (regardless of the patient's previous treatment history) and the first interferon therapy specifically approved for polycythemia vera
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Treatment of polycythemia vera includes bloodletting (phlebotomies; removing excess blood cells from a vein with a needle) and drugs that reduce the number of blood cells.
Ropeginterferon alfa-2b-njft is one of the drugs that can reduce the number of blood cells
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ropeginterferon alfa-2b-njft works by attaching to certain receptors in the body, triggering a chain reaction, thereby reducing the production of blood cells in the bone marrow
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ropeginterferon alfa-2b-njft is a long-acting drug that patients receive subcutaneous injection every two weeks
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If ropeginterferon alfa-2b-njft can reduce excess blood cells and maintain normal levels for at least one year, then the frequency of administration may be reduced to once every four weeks
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The efficacy and safety of ropeginterferon alfa-2b-njft were evaluated in a 7.
5-year multicenter, single-arm trial
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In this trial, 51 adult patients with polycythemia vera received ropeginterferon alfa-2b-njft for an average of about five years
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Complete hematological remission (red blood cell volume less than 45% and no recent exsanguination, normal white blood cell count and platelet count, normal spleen size and no blood clots) were used to evaluate the efficacy of ropeginterferon alfa-2b-njft
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Overall, 61% of patients achieved complete hematological remission
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ropeginterferon alfa-2b-njft can cause elevated liver enzymes, low white blood cell levels, low platelet levels, joint pain, fatigue, itching, upper respiratory tract infections, muscle pain, and flu-like illnesses
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Side effects may also include urinary tract infections, depression, and transient ischemic attacks
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Interferon therapy such as ropeginterferon alfa-2b-njft may cause or aggravate neuropsychiatric diseases, autoimmune diseases, ischemia (insufficient blood flow to a part of the body), and infectious diseases, leading to life-threatening or fatal complications
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Patients who are not allowed to use ropeginterferon alfa-2b-njft include patients who are allergic to drugs, patients with severe mental disorders or a history of severe mental disorders, immunosuppressive transplant recipients, patients with autoimmune diseases or autoimmune diseases And patients with liver disease
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