Has anyone moved from Pegasys to Ropeg?

[Paul123456]

Not sure if Ropeg is available in the U.K.? Is anyone here using it?

[JohnSC]

Yes I have been on Besremi (Ropeginterferon) for 6 months. I will giving an update on my experience so far in the next few days.

[katiewalsh in reply to JohnSC]

Please let us know.

[MPNBlog in reply to JohnSC]

Hi John SC, I'd also be very interested to hear how you have been getting on with Besremi. Best wishes.

[HFrank]

Hi John SC, I am very interested about your result with Ropeg too. The US FDA pre-approval inspection of the company’s manufacturing facility in Taiwan was enclosed in this week. And result is positive (Form 483: there is no major concerns). The PDUFA date is keep as 2021/11/13.

Best wish.

[EPguy in reply to HFrank]

That is good news. I've been following it for some time too. Here is some further details of the company's announcement. The company seems very confident.

Do you have better details about the 483?

From udn-com.translate.goog/news...

"Chinese medicine drug (6446) today (28) evening announcement, the US Food and Drug Administration ( the FDA ) has today completed the company's factory in Taichung GMP factory inspection work, check the time for the September 20 to September 28. This announcement by Yaohuayao means that the company will successfully obtain marketing authorization in the US drug market.

The Yaohuayao announcement stated that the FDA provided 483 reports in the summary meeting and stated that there were no major concerns. The FDA has no concerns about the quality of the product on the market, and requires the company to respond to its observations within 15 working days.

Yaohuayao pointed out that the company will respond to the observations raised by the FDA within the prescribed time limit as required by the FDA. Yaohuayao submitted to the US FDA an application for a new biologic drug certificate for Ropeginterferon alfa-2b (P1101) for the treatment of Polycythemia Vera (PV). The target date for completing the review of the drug certificate is November 13, 2021."

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However from below getting a 483 is not good. We can hope the company is honest that the 483 will be easily addressed and not lead to a "warning letter".

greenlight.guru/blog/fda-wa...

"Remember, the FDA isn’t messing around; if you receive a 483 observation, consider it to be fair warning that something isn’t quite right with your internal processes and it may be worth your time to look into those issues further."

[Manouche in reply to EPguy]

« An FDA 483 observation can be very expensive, resulting in thousands or even millions of dollars in costs for some companies. If the issues are systemic, the Form 483 observation can trigger training, redesign, process implementation, and other measures ».A bit too early to make any conclusion