One year af­ter Fetro­ja ap­proval, Sh­iono­gi ex­pands la­bel to in­clude dif­fi­cult-to-treat pneu­mo­nia

A year af­ter snag­ging ap­proval in com­pli­cat­ed uri­nary tract in­fec­tions, Sh­iono­gi’s an­tibi­ot­ic Fetro­ja has added an­oth­er in­di­ca­tion to its la­bel: hos­pi­tal-ac­quired and ven­ti­la­tor-as­so­ci­at­ed bac­te­r­i­al pneu­mo­nia.

The FDA OK was based on Phase III da­ta which showed the drug — chem­i­cal­ly known as ce­fide­ro­col — was non-in­fe­ri­or to high-dose meropen­em in all-cause mor­tal­i­ty (ACM) af­ter two weeks. Ac­cord­ing to the Japan­ese biotech, 12.4% of mod­i­fied in­tent-to-treat pa­tients on Fetro­ja died af­ter 14 days, com­pared to 12.2% of pa­tients on meropen­em.

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