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Third thread on $FGEN NDD opportunity.
So first, market size. On call yesterday, company said NDD pts with severe enough anemia to treat is around 2.5 million pts in US.
That is consistent with recent large survey on CKD pts in Denmark: https://www.dovepress.com/risk-of-anemia-in-patients-with-newly-identified-chronic-kidney-diseas-peer-reviewed-fulltext-article-CLEP#
So first, market size. On call yesterday, company said NDD pts with severe enough anemia to treat is around 2.5 million pts in US.
That is consistent with recent large survey on CKD pts in Denmark: https://www.dovepress.com/risk-of-anemia-in-patients-with-newly-identified-chronic-kidney-diseas-peer-reviewed-fulltext-article-CLEP#
Right now, only around 15% of NDD pts treated with ESA's - limits are because of reimbursement issues based on Hg levels, and non-oral treatment being an obstacle (obviously not issue in DD). I expect these obstacles to fall.
So TAM at a conservative $4k/yr price is $10 billion.
So TAM at a conservative $4k/yr price is $10 billion.
I do not believe vada is approvable for NDD, or if it scrapes by it will undoubtedly have a black box. This (unlike DD) will be sales-intensive market, so FGEN and $AZN should have it to itself, perhaps challenged eventually by $GSK.
This graph, and whether or not something like it appears on the label, will be key to speed of uptake. This is a non-prespecified subgroup based on still having decent kidney function, which is why the labeling doubt
That shows that roxa, when used on pts with eGFR > 15, prevents about 6 month's worth of decline in kidney function in a year. That plausibly delays dialysis by the same 6 month period - a simply huge cost and patient benefit.
I'm sure we will hear more about this at ASN, in addition to other quality of life issues - patients simply feel much better when their anemia is corrected. Be interesting to hear data on whether dialysis was indeed delayed or not. Clearly transfusions were avoided in roxa arm.
One other interesting datapoint from recent call - uptake in China has been very rapid, including among NDD pts. This is simply a huge population there that is presently severely undertreated given no transfusions and little use of ESAs outside dialysis.
That's all for now. If there is interest I can do a similar thread tomorrow on the DD opportunity.
