All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the MPN Advocates Network.
The mpn Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the mpn Hub cannot guarantee the accuracy of translated content. The mpn and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The MPN Hub is an independent medical education platform, sponsored by AOP Health and GSK, and supported through an educational grant from Bristol Myers Squibb and Incyte. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View MPN content recommended for you
FDA biologics license application of ropeginterferon alfa-2b resubmitted for the treatment of PV
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.
References
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content