John Butler, Akebia CEO

FDA to take an­oth­er look at Ake­bi­a's re­ject­ed kid­ney drug

Will the sec­ond re­view work out bet­ter than the first? Ake­bia Ther­a­peu­tics said this morn­ing that the FDA is tak­ing an­oth­er look at its com­plete re­sponse let­ter for its po­ten­tial treat­ment for ane­mia due to chron­ic kid­ney dis­ease, which was re­ject­ed last March due to safe­ty con­cerns.

The com­pa­ny, which saw its stock price fall by more than 65% at the time of the re­jec­tion of vadadu­s­tat, said the FDA had re­quest­ed a new tri­al and that the safe­ty ques­tions cen­tered on the drug’s “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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