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Re: dewophile post# 248200

Wednesday, 07/26/2023 12:09:23 PM

Wednesday, July 26, 2023 12:09:23 PM

Post# of 252233
Understandable to pull out under those circumstances. Was there any language on why the opinion was limited to DD?

Also see the note they will not be filing in other markets...

Haven't kept up with Roxa sales in the EU (or anywhere else) but it seems they were slower than astellas was looking for.


Additional from Evaluate Vantage

https://www.evaluate.com/vantage/articles/news/corporate-strategy-snippets/gsk-admits-anaemia-defeat

If Evrenzo cannot make a success of the anaemia market, what chance does Jesduvroq have? This seems to have been the question that led GSK management to call off its attempts to get the latter approved in new markets, a decision disclosed in its second-quarter results today. GSK had already pulled Jesduvroq’s filing in Europe after the CHMP recommended excluding non-dialysis patients from the project’s label, citing insufficient data to establish its safety in these patients. Withdrawing the filing was probably wise – even Fibrogen’s Evrenzo, with a label covering all patients regardless of dialysis requirements, is not doing well. A year ago, 2028 forecasts that would accrue to Astellas, which has rights in Europe and Japan, sat at $360m. Now they rest at just $99m, Evaluate Pharma consensus shows, possibly because an expensive product that only offers better convenience is struggling to make headway in a market dominated by the well known and now off patent EPO.

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