Besremi (ropeginterferon) authorized for polycythemia vera treatment in Korea

[HFrank]

koreabiomed.com/news/articl...

[Bobadog]

Many thanks for sharing this.I wonder if there is any positive news in the UK yet,regarding Besremi .

All the best

[hunter5582]

Good news. Besremi is supposed to up for approval in the USA in mid-November. 🤞

[EPguy in reply to hunter5582]

Their reply to FDA site inspection was due a couple days ago. I can't find any update on that however.

[hunter5582 in reply to EPguy]

It was an industry rep at a recent MPN Presentation that made reference to the ruling happening in mid-November. Hopefully it will be so.

[EPguy in reply to hunter5582]

That date was noted by the Company also last summer. We all hope it's a better result than last March's rejection (bec of Covid travel)

After the FDA inspection in Taiwan Sept 28, they were given 15 days to address some issues that were found, but the Co claims nothing major. So they likely sent it in last week. All this info I'm looking for of course doesn't actually affect anything we can do but I like to follow them anyway.

[Sam2022 in reply to hunter5582]

Hi, Hunter. Is it significantly better than PEGASUS in terms of efficacy? Good to hear US FDA is reviewing it and hopefully get approved soon. Thanks

[SoledadBarcelona]

Thanks. I am on Besremi and I would like to exchange ideas about it. Are you on it? Thanks

[Bobadog in reply to SoledadBarcelona]

Hi SoledadPresumably you live in Spain?

I don’t know anyone who is taking Besremi in the UK,or the London area yet?

Hope it’s going well for you,

Take care

[SoledadBarcelona in reply to Bobadog]

Thanks