In-house FDA re­view flags a sus­pi­cious im­bal­ance in deaths as Sh­iono­gi hunts an OK for an­tibi­ot­ic

Sh­iono­gi has some big ques­tions to an­swer if they plan to win an FDA pan­el’s back­ing for their new an­tibi­ot­ic.

While in­ves­ti­ga­tors have pro­vid­ed pos­i­tive ef­fi­ca­cy da­ta for their new prod­uct to treat cas­es of com­plex uri­nary tract in­fec­tions, an FDA re­view has flagged an im­bal­ance of deaths be­tween the an­tibi­ot­ic and a con­trol arm — with a “high­er mor­tal­i­ty in ce­fide­ro­col-treat­ed pa­tients was ob­served in a tri­al in crit­i­cal­ly ill pa­tients with a va­ri­ety of in­fec­tions due to car­bapen­em-re­sis­tant or­gan­isms.”

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