Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lex­i­con Phar­ma­ceu­ti­cal is not giv­ing up on its Type I di­a­betes can­di­date, de­spite FDA’s re­peat­ed re­jec­tions. This week the com­pa­ny laid out is ar­gu­ment again for a hear­ing on so­tagliflozin in re­sponse to the FDA’s most re­cent de­nial.

The is­sue goes back to March 2019 when the FDA made very clear to Lex­i­con and its now de­part­ed part­ner Sanofi that it would not ap­prove their ap­pli­ca­tion for a po­ten­tial Type I di­a­betes drug be­cause it does not ap­pear to be safe.

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