The clock is tick­ing for Iterum af­ter FDA hands down CRL for Pfiz­er castoff an­tibi­ot­ic

Iterum knew its odds were slim as it await­ed an FDA rul­ing on a key uri­nary tract in­fec­tion drug with its bank ac­count run­ning low. The FDA, how­ev­er, wasn’t im­pressed, and Iterum’s days look num­bered.

The FDA has sent the tiny biotech a com­plete re­sponse let­ter for the an­tibi­ot­ic su­lopen­em, shut­ting down hopes at get­ting the oral med­ica­tion across the fin­ish line, the drug­mak­er re­vealed Mon­day.

In Iterum’s telling of the de­tails — the let­ter was not made pub­lic — the FDA pushed back on the drug’s ap­pli­ca­tion in women with un­com­pli­cat­ed UTIs caused by “des­ig­nat­ed sus­cep­ti­ble mi­croor­gan­isms proven or strong­ly sus­pect­ed to be non-sus­cep­ti­ble to a quinolone” due to a lack of clin­i­cal da­ta.

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