FDA con­tin­ues to ques­tion Arde­lyx CKD drug's ef­fect on clin­i­cal out­comes ahead of ad­comm meet­ing

Arde­lyx is like­ly to face a hos­tile FDA ad­comm to­mor­row as out­side ex­perts weigh whether the po­ten­tial chron­ic kid­ney dis­ease drug ac­tu­al­ly pro­vides a clin­i­cal­ly mean­ing­ful ef­fect.

Back in Ju­ly 2021, the FDA re­ject­ed the drug for the con­trol of serum phos­pho­rus lev­els in adults with chron­ic kid­ney dis­ease on dial­y­sis, known as tena­panor, and the com­pa­ny’s sub­se­quent ap­peal. In brief­ing doc­u­ments ahead of to­mor­row’s meet­ing of the car­dio­vas­cu­lar and re­nal drugs ad­comm, the FDA made clear the ques­tion marks be­fore the agency:

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