FDA re­jects Reata's kid­ney drug af­ter ad­comm vot­ed unan­i­mous­ly against it

When an FDA ad­comm unan­i­mous­ly votes against a drug, it’s not al­ways guar­an­teed that the FDA will fol­low suit (e.g. Bio­gen’s Aduhelm). But in the case of Rea­ta’s bar­dox­olone, a po­ten­tial treat­ment to slow the pro­gres­sion of chron­ic kid­ney dis­ease in those with the rare Al­port syn­drome, the FDA sent a com­plete re­sponse let­ter late Fri­day.

Ac­cord­ing to Rea­ta, the FDA con­clud­ed it does not be­lieve the com­pa­ny has demon­strat­ed that bar­dox­olone is ef­fec­tive in slow­ing the loss of kid­ney func­tion in pa­tients with Al­port syn­drome, which af­fects about 30,000 to 60,000 peo­ple in the US. The FDA al­so re­quest­ed ad­di­tion­al da­ta to sup­port the ef­fi­ca­cy and safe­ty of bar­dox­olone.

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