FDA+ roundup: More than 2 years af­ter a CRL, Lex­i­con is still bat­tling the de­ci­sion; UK phar­ma in­dus­try weighs di­rec­tion of MHRA

Back in March 2019, the FDA made clear to Sanofi and its part­ner Lex­i­con Phar­ma­ceu­ti­cals that it couldn’t ap­prove the ap­pli­ca­tion for their di­a­betes drug be­cause the da­ta sub­mit­ted do not show that the drug is safe.

“The da­ta demon­strat­ed that the ad­di­tion of so­tagliflozin to in­sulin is as­so­ci­at­ed with an in­creased risk of di­a­bet­ic ke­toaci­do­sis (DKA), a se­ri­ous and of­ten life-threat­en­ing con­se­quence of in­sulin in­suf­fi­cien­cy,” the agency said in a rare ex­pla­na­tion of the com­plete re­sponse let­ter. “Time-to-event analy­ses of the clin­i­cal tri­al da­ta showed ear­li­er de­vel­op­ment of DKA in so­tagliflozin-treat­ed pa­tients than in pa­tients as­signed to place­bo, with­out ev­i­dence that the risk stopped in­creas­ing over time.”

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