Thursday, July 27, 2017 11:48:26 AM
FS yes .. I'm reading up on it
"Sales could grow much bigger than that in 2018, however, if the FDA approves Auryxia's use in stage 3 to 5 chronic kidney disease patients not on dialysis.
In phase 3 trials, Auryxia helped treat anemia in these patients, and the FDA has set a target action PDUFA date of Nov. 6 to decide on whether to expand the drug's label.
If it does, then it will significantly increase Auryxia's addressable patient population. An estimated 1.6 million Americans with stage 3 to 5 non-dialysis dependent chronic kidney disease have iron deficiency anemia."
Interesting story . So is there an Adcom before the FDA decision ?
High phosphorous levels are a serious problem and patients often have to take multiple pills to try and control .
I'll try and learn more ...currently just working on a sketchy understanding but "the play " appears to be expanded label ....hmm where have we discussed that before ...
Kiwi
PS ...note the high lighted area above ...wife's dept is more interested in FGEN's oral roxadustat for iron deficiency anemia in this population ...but will chk
"Sales could grow much bigger than that in 2018, however, if the FDA approves Auryxia's use in stage 3 to 5 chronic kidney disease patients not on dialysis.
In phase 3 trials, Auryxia helped treat anemia in these patients, and the FDA has set a target action PDUFA date of Nov. 6 to decide on whether to expand the drug's label.
If it does, then it will significantly increase Auryxia's addressable patient population. An estimated 1.6 million Americans with stage 3 to 5 non-dialysis dependent chronic kidney disease have iron deficiency anemia."
Interesting story . So is there an Adcom before the FDA decision ?
High phosphorous levels are a serious problem and patients often have to take multiple pills to try and control .
I'll try and learn more ...currently just working on a sketchy understanding but "the play " appears to be expanded label ....hmm where have we discussed that before ...
Kiwi
PS ...note the high lighted area above ...wife's dept is more interested in FGEN's oral roxadustat for iron deficiency anemia in this population ...but will chk
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