Up­dat­ed: In sur­prise turn, FDA ad­comm votes in fa­vor of Arde­lyx CKD drug de­spite agency ques­tions

Af­ter the FDA re­ject­ed and ques­tioned Arde­lyx’s po­ten­tial drug for the con­trol of serum phos­pho­rus lev­els in adults with chron­ic kid­ney dis­ease on dial­y­sis, the FDA’s Car­dio­vas­cu­lar and Re­nal Drugs ad­vi­so­ry com­mit­tee on Wednes­day vot­ed 9-4 in fa­vor of the drug as a monother­a­py, and 10-2 (with one ab­sten­tion) in fa­vor of the drug when ad­min­is­tered in com­bo with phos­phate binder treat­ment.

Ad­comm com­mit­tee chair Ju­lia Lewis of Van­der­bilt Med­ical Cen­ter said the drug, known as tena­panor, of­fers small­er pills, and al­though it may see less ef­fi­ca­cy than the cur­rent stan­dard of care, there’s a small sub­set of CKD pa­tients who will re­spond to monother­a­py and “let’s make that avail­able to them.”

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