FDA snubs Sanofi, Lex­i­con on their pitch for SGLT1/2 di­a­betes drug so­tagliflozin, com­pa­nies mum on what went wrong

Sanofi’s shot at a last-place show­ing for its SGLT1/SGLT2 di­a­betes drug has end­ed in a painful prat­fall ahead of the fin­ish line. The phar­ma gi­ant and their part­ners at Lex­i­con $LXRX say that so­tagliflozin, a ma­jor play­er for their di­a­betes port­fo­lio, has been re­ject­ed by the FDA.

Their terse re­lease gave no ex­pla­na­tion for what went wrong, but an ex­pert pan­el pro­vid­ed a split vote on the mon­ey ques­tion re­gard­ing safe­ty and ef­fi­ca­cy, with in­sid­ers at the agency field­ing big con­cerns about ev­i­dence of di­a­bet­ic ke­toaci­do­sis.

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