Fi­bro­Gen, As­traZeneca ready Chi­na ap­pli­ca­tion as ane­mia drug scores in two piv­otal stud­ies

Fi­bro­gen $FGEN and As­traZeneca $AZN took a big step to­ward com­plet­ing their new drug ap­pli­ca­tion in Chi­na for the ane­mia drug rox­adu­s­tat af­ter hit­ting the pri­ma­ry end­points in two Phase III stud­ies in the key Asian mar­ket.

Chron­ic kid­ney dis­ease pa­tients tak­ing rox­adu­s­tat (FG-4592 or 罗沙司他) gained a mean av­er­age of 1.9g/dL in he­mo­glo­bin lev­els, com­pared to a drop of -0.4g/dL in the place­bo group. And 84% of the pa­tients had a sig­nif­i­cant in­crease in he­mo­glo­bin re­sponse, com­pared to none in the place­bo arm.

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