FDA approves Akebia’s anemia drug after saying no in 2022

The FDA on Wednes­day green­lit Ake­bia Ther­a­peu­tics’ treat­ment for ane­mia due to chron­ic kid­ney dis­ease, mark­ing a turn­around for vadadu­s­tat, which the FDA re­ject­ed al­most two years ago to the day over safe­ty con­cerns.

The Cam­bridge, MA-based biotech will mar­ket vadadu­s­tat as Vaf­seo. The once-dai­ly tablets are in­di­cat­ed for adult pa­tients who have been on dial­y­sis for at least three months.

The pre­scrib­ing la­bel comes with a black box warn­ing for in­creased risk of death, my­ocar­dial in­farc­tion, stroke, ve­nous throm­boem­bolism and throm­bo­sis of vas­cu­lar ac­cess.

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