FDA grants ap­peal for Arde­lyx chron­ic kid­ney dis­ease drug af­ter Ju­ly 2021 re­jec­tion

The FDA be­stowed good tid­ings up­on Arde­lyx’s ex­per­i­men­tal chron­ic kid­ney dis­ease drug Thurs­day morn­ing.

Reg­u­la­tors told the biotech they would hear an ap­peal to its com­plete re­sponse let­ter, po­ten­tial­ly set­ting Arde­lyx up for an ap­proval re­sub­mis­sion in the first half of next year. The move fol­lows a post-CRL ad­vi­so­ry com­mit­tee meet­ing last month in which the FDA’s Car­dio­vas­cu­lar and Re­nal Drugs pan­elists vot­ed in fa­vor of both monother­a­py and com­bi­na­tion reg­i­men ap­provals.

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