$fgen The CKD Anemia Market Historically Dominated by ESAs. However, the emergence of safety issues including CV adverse events and subsequent "black box" warnings by FDA has led to a reduction in the value of some of these franchises such as Epogen/Aranesp.
Fast forward with recent positive safety data reported by $fgen roxadustat it is very likely this drug will be disruptive to ESAs in the coming years. Given historical issues with ESAs.
Let’s also not forget the administration sign an Executive Order on advancing American kidney health. Roxadustats oral utility fits the bill 100%.
I will also say that EPO use to be a 10bln market but dropped substantially due to safety and bb warning. 3.0+ Billion US Market Opportunity for HIF-PHI, in both the DD and NDD. The initial adoption in the dialysis setting will be quick as a result of TDAPA (outside of bundle).
There is also an opportunity to grow the non-dialysis (CKD stages 3, 4, 5) market where treatment rates with ESAs have declined due to safety concerns. $fgen is already seeing that with their most recent 5mln in revs booked in China coming from NDD.
Bottom line pay very close attention to $fgen the company will be very disruptive in the next few years & will cause a major shift in the EPO market esp if Roxadustat gets a clean label w/no black box warning. Going against Placebo has and always will be the gold-standard.
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