Sh­iono­gi cel­e­brates an­tibi­ot­ic win in pneu­mo­nia just ahead of its date with FDA reg­u­la­tors

Just weeks be­fore Sh­iono­gi is sched­uled to hear back from the FDA on treat­ing com­pli­cat­ed uri­nary tract in­fec­tions with its an­tibi­ot­ic, the Japan­ese phar­ma has an­oth­er slate of pos­i­tive da­ta on a dif­fer­ent in­di­ca­tion to share.

In­ves­ti­ga­tors laid out the full num­bers on ce­fide­ro­col in adults with noso­co­mi­al pneu­mo­nia caused by gram-neg­a­tive pathogens — a par­tic­u­lar­ly tough to beat con­di­tion for hos­pi­tal­ized pa­tients, giv­en its mul­ti­ple re­sis­tance mech­a­nisms. In a Phase III, the drug ap­peared non-in­fe­ri­or to high-dose meropen­em in all-cause mor­tal­i­ty af­ter two weeks of treat­ment.

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