In­ves­ti­ga­tors sig­nal thumbs-up for an­tibi­ot­ic, prep an FDA pitch for OK

In­ves­ti­ga­tors for Sh­iono­gi say they’re prep­ping an FDA ap­pli­ca­tion for a new an­tibi­ot­ic af­ter round­ing up sol­id com­par­i­son da­ta in a piv­otal study.

Ce­fide­ro­col (or S-649266) hit its marks for a Gram-neg­a­tive study, prov­ing non-in­fe­ri­or to imipen­em/cilas­tatin when used to treat a com­pli­cat­ed uri­nary tract in­fec­tion.

The ef­fi­ca­cy da­ta on Ce­fide­ro­col was good: 72.6% of the new an­tibi­ot­ic arm was cured com­pared to 54% of the imipen­em arm. And few­er pa­tients ex­pe­ri­enced a se­ri­ous ad­verse event: 4.7% ver­sus 8.1%.

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