FDA rais­es safe­ty, ef­fi­ca­cy ques­tions for Fi­bro­Gen's ane­mia drug rox­adu­s­tat with ad­comm on the hori­zon

Ahead of Thurs­day’s meet­ing of the FDA’s Car­dio­vas­cu­lar and Re­nal Drugs Ad­vi­so­ry Com­mit­tee, the agency is rais­ing fresh doubts on whether Fi­bro­Gen’s ane­mia drug rox­adu­s­tat will cross the fin­ish line.

New safe­ty ques­tions for rox­adu­s­tat, a first-in-class in­hibitor of HIF-PH en­zymes, are emerg­ing in the FDA’s brief­ing doc­u­ments as the drug has been crit­i­cized for ma­nip­u­lat­ing car­dio­vas­cu­lar safe­ty da­ta af­ter it had to dou­ble back and in­form the FDA of some post-hoc sta­tis­ti­cal changes that some Wall Street an­a­lysts like Michael Yee at Jef­feries said were ma­te­r­i­al.

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