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FDA approval of ropeginterferon alfa-2b-njft for the treatment of adult patients with polycythemia vera

Nov 15, 2021
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On November 12, 2021, it was announced that the U.S. Food and Drug Administration (FDA) approved ropeginterferon alfa-2b-njft, a monopegylated, long-acting interferon, for the treatment of adult patients with polycythemia vera. The decision was based on results from the PEGINVERA (NCT01193699) and PROUD/CONTINUATION-PV studies (NCT01949805 and NCT02218047, respectively).1

After 7.5 years of treatment, complete hematologic response, which was defined as a hematocrit of <45% without phlebotomy for at least 2 months, a platelet count ≤400 × 109/L, a leukocyte count ≤10 × 109/L, and a normal spleen size (longitudinal diameter ≤12 cm for females and ≤13 cm for males), was achieved in 61% of patients in the PEGINVERA trial. Also, based on objective laboratory parameters only, (with the exclusion of normal spleen size and thrombosis), a hematologic response was achieved in 80% of patients.1

Pooled safety data from the trials showed serious adverse reactions with an incidence >4% included urinary tract infections, transient ischemic attacks, and depression; while the most common adverse reactions, with an incidence >40%, included influenza-like illness, arthralgia, fatigue, pruritis, nasopharyngitis, and musculoskeletal pain.1

The recommended dose of ropeginterferon alfa-2b-njft is once every 2 weeks until hematologic parameters are stabilized. After a year, those with a stable complete hematologic response can be treated once every 4 weeks. This allows a flexible dosing that can help meet the individual needs of a patient.1

Ropeginterferon alfa-2b-njft has previously received orphan drug designation by the FDA and is already approved in Europe, Taiwan, and South Korea for this indication.1

For more information on the 5-year results from the PROUD-PV and CONTINUATION-PV studies read our summary article here.

  1.  U.S. FDA approves Besremi® (ropeginterferon alfa-2b-njft) as the only interferon for adults with polycythemia vera. https://hq.pharmaessentia.com/uploads/images/%E2%95%96s%E2%95%97D%E2%96%91%E2%95%A9%E2%95%91A/latest%20news/202111/BESREMi%20FDA%20Approval%20November%2012%202021%20HQ.pdf
     Published Nov 12, 2021. Accessed Nov 15, 2021.

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