FDA Issues Complete Response Letter for Ropeginterferon Alfa-2b for Polycythemia Vera

[Manouche]

« The FDA has issued a complete response letter regarding the biologics license application for ropeginterferon alfa-2b-njft for the treatment of patients with polycythemia vera »

onclive.com/view/fda-issues...

[EmeraldA]

So reading this does this mean that people with splenomegaly would not be suitable for this treatment do you think?

[Manouche in reply to EmeraldA]

It means that other medications could be added to Besremi, eg ruxolitinib, etc...

[EmeraldA in reply to Manouche]

Ah right that is good to know. As always thanks for the interesting links you put up. B

[Aneliv9]

I am sorry but i didn't understand what this is all about!!

[jmctrek in reply to Aneliv9]

I think the gist of the article is that the FDA is still reviewing PharmaEssentia’s application after some COVID-related delays. The FDA is requesting for more information and PharmaEssentia is optimistic they can provide the data needed and resubmit the application in a short amount of time.

[Bluetop]

Thanks for posting -I wonder when it will be similarly available in UK.

[JohnSC in reply to Bluetop]

Hi, it is available in the UK. It is marketed as Besremi but it is not yet available via the NHS. You have to go private and it is not cheap.

[Bluetop in reply to JohnSC]

Thanks for clarifying. I wonder how long before NHS will offer it.

[JT_Marlin]

Great news! Wonder when it will get final approval

[jmctrek]

Thanks for sharing. Encouraging to see some progress. Hopefully there will be an FDA application for its use in the treatment of ET patients in the near future.