Ake­bia to re­file ane­mia drug vadadu­s­tat af­ter FDA de­nied ap­peal

The FDA still won’t ap­prove Ake­bia’s drug for ane­mia due to chron­ic kid­ney dis­ease, but the agency is ap­par­ent­ly keep­ing the door open to a re­sub­mis­sion — with­out ask­ing for new clin­i­cal da­ta for vadadu­s­tat.

It would mark a re­ver­sal from the FDA’s pre­vi­ous stance. When reg­u­la­tors first re­ject­ed vadadu­s­tat due to safe­ty con­cerns, they sug­gest­ed that the com­pa­ny need­ed to demon­strate the ben­e­fit-risk pro­file of the drug through ad­di­tion­al clin­i­cal tri­als.

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