While fig­ur­ing out post-CRL fu­ture for rox­adu­s­tat, Fi­bro­Gen cel­e­brates Eu­rope OK with Astel­las

The FDA may not be ready to ap­prove Fi­bro­Gen’s rox­adu­s­tat be­fore it sees an­oth­er clin­i­cal tri­al, but the Eu­ro­pean Com­mis­sion is swing­ing its doors wide open.

The oral HIF-PH in­hibitor known as rox­adu­s­tat will now be brand­ed Evren­zo in Eu­rope, to be pre­scribed for adult pa­tients with symp­to­matic ane­mia as­so­ci­at­ed with chron­ic kid­ney dis­ease.

By mim­ic­k­ing the ef­fect of high al­ti­tude in hu­mans, rox­adu­s­tat is de­signed to stim­u­late the pro­duc­tion of red blood cells and there­fore in­crease he­mo­glo­bin lev­els. It’s a dif­fer­ent mech­a­nism of ac­tion than the tra­di­tion­al in­jectable ery­thro­poiesis-stim­u­lat­ing agents — which was ini­tial­ly tout­ed as an ad­van­tage but al­so presents a high bar in terms of both adop­tion and safe­ty.

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