Monday, March 06, 2023 11:35:31 PM
Thanks for the detailed answer. It looks like the PRX-102 has many years on the market if approved with these three competitors.It's hard to imagine that PRX-102, having shown significantly better results than Replagal in the BRIDGE study may not be approved in Europe.I wonder if the infusion regimen every four weeks will be included in the pending approval or will it take some more time?This is one of the very important points that will allow the drug to penetrate the market quickly enough.Here is a quote from an article I post here a year ago -
"Even if eGFR improvements are not particularly differentiated among pegunigalsidase alfa and Fabrazyme, a majority of patients would likely switch to pegunigalsidase alfa if a more infrequent dosing schedule is approved, Nedd added. Given that Fabry disease runs in families, patients tend to be more knowledgeable of treatment developments than many other patient groups, making it easier for new drugs to gain market traction, he explained." In many ways, the doctors interviewed in this article turned out to be right.
https://www.clinicaltrialsarena.com/comment/protalixs-phase-iii-asset-for-fabry-could-struggle-to-demonstrate-superiority-over-fabrazyme-but-immunogenicity-benefits-support-regulatory-chances-experts-say/
I recently checked out what Fabry Disease News is writing about Protalix.The last article there dated Aug 20-2021. The site, I think, is read by many people with this disease.
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