FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Fri­day ap­proved Lex­i­con’s heart fail­ure drug so­tagliflozin fol­low­ing a string of set­backs for the phar­ma com­pa­ny, in­clud­ing an FDA re­jec­tion in di­a­betes and the loss of a de­vel­op­ment deal with Sanofi.

The dual SGLT1 and SGLT2 in­hibitor will be mar­ket­ed as In­pe­fa and is a once-dai­ly tablet. It’s been ap­proved to re­duce the risk of car­dio­vas­cu­lar death and heart fail­ure-re­lat­ed hos­pi­tal­iza­tion or ur­gent vis­its in adults with heart fail­ure or type 2 di­a­betes mel­li­tus, chron­ic kid­ney dis­ease, and oth­er car­dio­vas­cu­lar risk fac­tors. The la­bel spans the range of left ven­tric­u­lar ejec­tion frac­tion, in­clud­ing pre­served ejec­tion frac­tion and re­duced ejec­tion frac­tion, as well as pa­tients with or with­out di­a­betes, Lex­i­con said Fri­day.

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