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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER