PharmaEssentia Resubmits Application to the U.S. FDA For Ropeginterferon alfa-2b-njft to Treat Polycythemia Vera (PV)

[Manouche]

« The resubmission follows receipt of a complete response letter in March, in which the FDA sought additional information about the administration format with the product. Importantly, no concerns were raised about the clinical profile of the product. Also noted were COVID-related restrictions that delayed the required pre-approval inspection of the company’s manufacturing facility in Taiwan. »

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[MPNBlog]

Hi Manouche. Thanks for the update. Fingers crossed that it has more success with their submision this time for all the US PV sufferers.

[Manouche in reply to MPNBlog]

Ni doubt it’ll be approved although it seems we are back to square one with the administrative procedure!

[welshhuw]

Thank you for posting the update. I’m hoping that eventually Ropeg will get approval by NICE and will become available on the NHS in the UK. Hopefully before Pegasys production stops since there is no alternative pegylated interferon that is available in the UK that I am aware of. That being said, the main indication for Ropeg is in PV, so as an ET patient I suspect it may be another case of ‘off label’ treatment with all the fights and angst that we ensue. Anyway, fingers crossed.

[Manouche in reply to welshhuw]

NICE regularly communicates with other national agencies in Europe, like IQWIG in Germany. Therefore, I’m not very optimistic in the short term ( short term only!).

« In summary, in consideration of the combined findings on mortality, morbidity, and side effects, an additional benefit has not been proven for ropeginterferon alfa-2b over hydroxyurea in adult patients with polycythaemia vera without symptomatic splenomegaly not pretreated with hydroxyurea or pretreated with hydroxyurea who are not resistant or intolerant to hydroxyurea. »

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