Safe­ty con­cerns lead FDA to re­ject Ake­bi­a's kid­ney drug

The FDA on Wednes­day re­ject­ed Ake­bia Ther­a­peu­tics’ vadadu­s­tat, once a fron­trun­ner to treat ane­mia due to chron­ic kid­ney dis­ease, due to safe­ty con­cerns.

In is­su­ing a CRL, the com­pa­ny, which saw its stock price fall by more than 65% this af­ter­noon, said in a state­ment that the FDA has re­quest­ed an ad­di­tion­al tri­al and that the safe­ty ques­tions cen­tered on the drug’s “fail­ure to meet non-in­fe­ri­or­i­ty in MACE in the non-dial­y­sis pa­tient pop­u­la­tion, the in­creased risk of throm­boem­bol­ic events, dri­ven by vas­cu­lar ac­cess throm­bo­sis in dial­y­sis pa­tients, and the risk of drug-in­duced liv­er in­jury.”

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