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FDA biologics license application of ropeginterferon alfa-2b resubmitted for the treatment of PV

May 17, 2021
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Polycythemia vera (PV) is a subtype of myeloproliferative neoplasms, characterized by excessive red blood cell production, which may lead to thromboembolic events. PV may transform into secondary myelofibrosis or leukemia over time. Ropeginterferon alfa-2b, a novel mono-pegylated alfa interferon, is currently under evaluation by the U.S. Food and Drug Administration (FDA) for the treatment of PV.

Following a complete response letter, the biologics license application for ropeginterferon alfa-2b was recently resubmitted to the FDA.1 Ropeginterferon alfa-2b holds orphan drug designation in the United States.

A biologics license application was previously submitted in June 2020 based on positive results from the phase III PROUD/CONTINUATION-PV study, which investigated the efficacy and safety of ropeginterferon alfa-2b compared with hydroxyurea/best available therapy in patients with PV. The FDA issued a complete response letter to seek additional information on the administration format with no concerns over the clinical profile of the product in March 2021. Information requests have been addressed with the current resubmission.

Ropeginterferon alfa-2b was approved by the European Medicines Agency (EMA) for the treatment of PV without symptomatic splenomegaly in 2019.2

Additional content

Click here for a summary of the 5-year results from the PROUD-PV/CONTINUATION-PV studies.

Click here for a subanalysis of the PROUD-PV trial according to age.

  1. BusinessWire.PharmaEssentia resubmits application to the U.S. FDA for ropeginterferon alfa-2b-njft to treat polycythemia vera (PV). https://www.businesswire.com/news/home/20210514005106/en/. Published May 14, 2021. Accessed May 17, 2021.
  2. European Medicines Agency. Besremi. https://www.ema.europa.eu/en/medicines/human/EPAR/besremi. Accessed May 17, 2021.

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