As­traZeneca, Fi­bro­Gen flag ap­peal­ing pooled safe­ty da­ta on roxa for key seg­ment of the CKD mar­ket

As­traZeneca rolled out its pooled haz­ard ra­tios on rox­adu­s­tat safe­ty to­day, which helps map out how they plan to take on the huge ane­mia mar­ket for chron­ic kid­ney dis­ease pa­tients who have re­lied on EPO for decades — pro­vid­ed the FDA comes through with an OK.

The ba­sic break­down has to ad­dress 2 dif­fer­ent reg­u­la­to­ry stan­dards, us­ing MACE for the FDA and MACE+ for Eu­ro­pean reg­u­la­tors, where guide­lines add con­ges­tive heart fail­ure and angi­na hos­pi­tal­iza­tions to the mix of car­dio threats. Re­searchers have al­ready out­lined ap­peal­ing ef­fi­ca­cy num­bers. But As­traZeneca’s part­ner — Fi­bro­Gen — spooked an­a­lysts and in­vestors back in May when they fudged the top-line state­ment in­di­cat­ing there could be re­al trou­ble in key mar­ket seg­ments. The part­ners, though, ap­pear to have skirt­ed the worst-case sce­nario un­der­scored by a re­cent short at­tack, ex­pect­ing that key haz­ard ra­tios could scut­tle the drug en­tire­ly.

There was a clear step up in risk as in­ves­ti­ga­tors as­sessed the drug against place­bo for non-dial­y­sis CKD pa­tients, against EPO in dial­y­sis pa­tients, and against a pop­u­la­tion of pa­tients new-to-dial­y­sis, called in­ci­dent dial­y­sis.

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