On the heels of Chi­na ap­proval, Fi­bro­Gen and As­traZeneca spot­light more pos­i­tive PhI­II da­ta for rox­adu­s­tat

Days af­ter Fi­bro­Gen and As­traZeneca scored their first ap­proval for rox­adu­s­tat — in Chi­na — the part­ners say they have more Phase III da­ta to sup­port their up­com­ing pitch­es in the US and oth­er coun­tries.

The ane­mia drug hit the pri­ma­ry end­points of both OLYM­PUS and ROCK­IES: A sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in mean change from base­line in Hb lev­els av­er­aged over weeks 28 to 52.

The two tri­als dif­fer in two main as­pects: In OLYM­PUS, the chron­ic kid­ney dis­ease pa­tients are not de­pen­dent on dial­y­sis, and the com­para­tor arm con­sists of a place­bo; while ROCK­IES in­volve dial­y­sis-de­pen­dent pa­tients and com­pares rox­adu­s­tat against epo­et­in al­fa, an ana­log of the nat­u­ral­ly oc­cur­ring ery­thro­poi­etin.

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