De­spite wor­ries trig­gered by im­bal­ance of deaths, Sh­ionogi's an­tibi­ot­ic clears FDA pan­el vote

Con­cerns over dis­pro­por­tion­ate mor­tal­i­ty had not stopped a pan­el of ex­perts to rec­om­mend that the FDA ap­prove Sh­iono­gi’s an­tibi­ot­ic ce­fide­ro­col for com­pli­cat­ed uri­nary tract in­fec­tions, rais­ing hopes of an OK next month.

Af­ter dis­cussing the im­bal­ance in deaths be­tween the ce­fide­ro­col and con­trol arms flagged by the agency’s in-house re­view, the ma­jor­i­ty of the An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee vot­ed in fa­vor of the drug. More specif­i­cal­ly, 14 agreed that there’s sub­stan­tial ev­i­dence of ef­fi­ca­cy and safe­ty for ce­fide­ro­col in treat­ing cU­TI, while two vot­ed against.

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