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

Nov 15, 2021

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.
     Published Nov 12, 2021. Accessed Nov 15, 2021.