Will third time be the charm? Lex­i­con fi­nal­ly re­files SGLT2 drug for heart fail­ure

Lex­i­con’s ex­per­i­men­tal treat­ment of heart fail­ure is fi­nal­ly on its way to the FDA — again.

The Wood­lands, TX-based biotech says it’s re­sub­mit­ted an NDA to the FDA seek­ing to mar­ket so­tagliflozin as a treat­ment for heart fail­ure, kick­ing off the 60-day re­view pe­ri­od.

The re­sub­mis­sion comes al­most ex­act­ly four years af­ter US reg­u­la­tors first ac­cept­ed so­tagliflozin for re­view. Back in 2018, it was Lex­i­con’s then-part­ner, Sanofi, that did the fil­ing. The com­pa­nies had giv­en the drug a brand name — Zyn­quista — and were tout­ing how, if ap­proved, it would be the first oral treat­ment op­tion for adults with type 1 di­a­betes, in com­bi­na­tion with in­sulin.

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