Boehringer Ingelheim, Eli Lilly clinch new FDA approval for blockbuster Jardiance to treat chronic kidney disease

Boehringer In­gel­heim and Eli Lil­ly nabbed a sec­ond FDA ap­proval for block­buster Jar­diance (em­pagliflozin), this time to treat adults with chron­ic kid­ney dis­ease, the com­pa­nies an­nounced Fri­day.

The FDA gave its stamp of ap­proval for 10 mg tablets of the type 2 di­a­betes drug to low­er the risk of sus­tained de­cline in es­ti­mat­ed glomeru­lar fil­tra­tion rate, end-stage kid­ney dis­ease, car­dio­vas­cu­lar death and hos­pi­tal­iza­tion in those with chron­ic kid­ney dis­ease (CKD) at risk of pro­gres­sion, the com­pa­nies said. The ap­proval is based on pos­i­tive re­sults from the com­pa­nies’ EM­PA-KID­NEY tri­al, which en­rolled 6,600 adults with CKD or type 2 di­a­betes.

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