Safe­ty con­cerns push FDA ad­comm to vote over­whelm­ing­ly against ap­proval for Fi­bro­Gen ane­mia drug

The FDA’s Car­dio­vas­cu­lar and Re­nal Drugs Ad­vi­so­ry Com­mit­tee on Thurs­day af­ter­noon vot­ed 12 to 2 against ap­prov­ing As­traZeneca and Fi­bro­Gen’s ane­mia drug rox­adu­s­tat as a treat­ment of ane­mia due to chron­ic kid­ney dis­ease in adult pa­tients on dial­y­sis, and the com­mit­tee vot­ed 13-1 against ap­proval for pa­tients not on dial­y­sis.

Over­all, ad­comm mem­bers raised ques­tions re­lat­ed to the car­dio­vas­cu­lar safe­ty of the drug and a lack of a sig­nal re­lat­ed to qual­i­ty-of-life im­prove­ments, un­der-rep­re­sen­ta­tion of African Amer­i­cans in the glob­al tri­als, as well as con­cerns with the com­pa­ny’s planned post-mar­ket­ing study and dos­ing changes.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER