De­sert­ed by Sanofi, Lex­i­con dis­clos­es last-minute hic­cup in its so­lo fight to get so­tagliflozin ap­proved

When the FDA first snubbed Sanofi and Lex­i­con’s NDA for so­tagliflozin back in 2019, the re­jec­tion quashed their hopes of scor­ing a last-place fin­ish in the SGLT drug race in di­a­betes. But the com­pa­nies vowed to look in­to next steps.

Al­most three years, two failed ap­peals and a breakup lat­er, Lex­i­con says it’s still not quite ready.

The biotech — based out of The Wood­lands, TX — dis­closed Mon­day that it’s with­drawn its re­sub­mis­sion of an NDA “to cor­rect a tech­ni­cal is­sue with the sub­mis­sion re­cent­ly iden­ti­fied by the com­pa­ny.”

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