Eas­ing con­cerns, Fi­bro­Gen, As­traZeneca se­cure FDA date for their ane­mia drug in broad chron­ic kid­ney dis­ease pop­u­la­tion

Armed with a new chief fol­low­ing the un­ex­pect­ed pass­ing of long­time CEO Thomas Neff last year, Fi­bro­Gen is off to the races with its con­tro­ver­sial As­traZeneca-part­nered ane­mia drug. The FDA has ac­cept­ed the com­pa­ny’s ap­pli­ca­tion to mar­ket the oral ther­a­py — which is po­si­tioned to re­place the stan­dard of care — in pa­tients with chron­ic kid­ney dis­ease re­gard­less of dial­y­sis sta­tus.

The drug, rox­adu­s­tat, which is de­signed to stim­u­late the pro­duc­tion of red blood cells by mim­ic­k­ing the ef­fect of high al­ti­tude in hu­mans was ap­proved in Chi­na last year — mark­ing per­haps the first in­stance of a multi­na­tion­al phar­ma­ceu­ti­cal com­pa­ny As­traZeneca paving the way for the sale of a med­i­cine in Chi­na, be­fore the Unit­ed States or Eu­rope.

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