Bay­er takes SGLT2 hope­fuls head on with FDA ap­proval for new kid­ney dis­ease drug

The FDA on Fri­day ap­proved Bay­er Phar­ma­ceu­ti­cals’ chron­ic kid­ney dis­ease drug Keren­dia (finerenone), the first and on­ly non­s­teroidal min­er­alo­cor­ti­coid re­cep­tor an­tag­o­nist, of­fer­ing a new op­tion for CKD. While ri­val SGLT2 in­hibitors may damp­en the mar­ket prospects for Keren­dia, Bay­er says the com­pe­ti­tion is mis­guid­ed as it’s pro­ject­ing at least $1 bil­lion in an­nu­al sales.

The pos­i­tive, place­bo-con­trolled tri­al that led to the ap­proval, pub­lished in the New Eng­land Jour­nal of Med­i­cine in De­cem­ber, showed how Keren­dia sig­nif­i­cant­ly re­duced the risks of CKD pro­gres­sion and car­dio­vas­cu­lar events when com­pared with place­bo. The treat­ment is now in­di­cat­ed to slow CKD pro­gres­sion, re­duce the risk of end stage kid­ney dis­ease, car­dio­vas­cu­lar death, non-fa­tal my­ocar­dial in­farc­tion, sus­tained eGFR de­cline, and hos­pi­tal­iza­tion for heart fail­ure in adults with CKD as­so­ci­at­ed with type 2 di­a­betes.

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