FDA slams Reata's kid­ney drug as in­ef­fec­tive ahead of ad­comm meet­ing

The FDA on Mon­day of­fered an over­whelm­ing­ly neg­a­tive opin­ion on Rea­ta Phar­ma­ceu­ti­cals’ po­ten­tial drug to slow the loss of kid­ney func­tion in those with the rare dis­ease Al­port syn­drome, ac­cord­ing to brief­ing doc­u­ments re­leased ahead of an ad­vi­so­ry com­mit­tee meet­ing Wednes­day.

The agency’s re­view team said it “does not be­lieve the sub­mit­ted da­ta demon­strate that bar­dox­olone is ef­fec­tive in slow­ing the loss of kid­ney func­tion in pa­tients with AS and re­duc­ing the risk of pro­gres­sion to kid­ney fail­ure.” Orig­i­nal­ly de­vel­oped as a can­cer drug, bar­dox­olone was lat­er scut­tled by Rea­ta al­most a decade ago as a chron­ic kid­ney dis­ease drug due to deaths in a Phase III tri­al.

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