Iterum says FDA is in 'gen­er­al align­men­t' on pro­posed new PhI­II for re­ject­ed uU­TI drug

Iterum Ther­a­peu­tics is paint­ing a rosier pic­ture of its once-re­ject­ed an­tibi­ot­ic af­ter meet­ing with the FDA last week.

The agency was in “gen­er­al align­ment” with the Dublin and Chica­go-based biotech af­ter dis­cussing a pro­posed ad­di­tion­al Phase III clin­i­cal study of su­lopen­em for un­com­pli­cat­ed uri­nary tract in­fec­tions, or uU­TI, Iterum said Wednes­day.

Next up is an agree­ment re­quest with the reg­u­la­tor for a spe­cial pro­to­col as­sess­ment of the clin­i­cal tri­al, which will be a non-in­fe­ri­or­i­ty study com­par­ing Iterum’s oral drug to amox­i­cillin clavu­lanate, an an­tibi­ot­ic once in­volved in a le­gal dis­pute be­tween Glax­o­SmithK­line and No­var­tis over gener­ics pro­duc­tion, in adult women.

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