FDA un­ex­pect­ed­ly de­lays roxa de­ci­sion, foil­ing Fi­bro­Gen's Feb­ru­ary roll­out plans

Months af­ter an­a­lysts pre­dict­ed Fi­bro­Gen had an ap­proval in the bag for its chron­ic kid­ney dis­ease-re­lat­ed ane­mia drug rox­adu­s­tat, the FDA has ex­tend­ed its re­view pe­ri­od an­oth­er three months.

As­traZeneca, which is part­nered with Fi­bro­Gen on the drug, an­nounced that the FDA has re­quest­ed “fur­ther clar­i­fy­ing analy­ses of clin­i­cal da­ta,” and moved the Dec 20 PDU­FA date to March 20.

“Fi­bro­Gen is work­ing close­ly with the FDA, in col­lab­o­ra­tion with our part­ner, As­traZeneca, to sup­port the fi­nal re­view of the new drug ap­pli­ca­tion for rox­adu­s­tat,” Fi­bro­Gen CEO En­rique Con­ter­no said in a state­ment. He told End­points News ear­li­er this week that the com­pa­ny had been plan­ning for a Feb­ru­ary roll­out if the drug were ap­proved.

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