FDA re­jects Fi­bro­Gen's ane­mia drug, de­mand­ing an ad­di­tion­al clin­i­cal tri­al

Less than a month since an FDA ad­comm vot­ed al­most unan­i­mous­ly against ap­prov­ing As­traZeneca and Fi­bro­Gen’s ane­mia drug rox­adu­s­tat as a treat­ment of ane­mia due to chron­ic kid­ney dis­ease, the FDA has sent over a re­jec­tion let­ter and re­quest­ed an ad­di­tion­al clin­i­cal study pri­or to re­sub­mis­sion.

While the re­jec­tion is not a com­plete sur­prise (shares of Fi­bro­Gen stock ticked up slight­ly Wednes­day morn­ing, fol­low­ing a near­ly 40% plunge af­ter the ad­comm), it re­mains un­clear if the two com­pa­nies will have the ap­petite to run an­oth­er clin­i­cal tri­al, giv­en the car­dio­vas­cu­lar safe­ty con­cerns and qual­i­ty-of-life ques­tion marks.

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