Motif's antibiotic gets Priority Review

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said FDA accepted and granted Priority Review to an NDA for iclaprim (MTF-100) to treat acute bacterial skin and skin structure infections (ABSSSIs). Its PDUFA date is Feb. 13, 2019.

The NDA includes data from the identical Phase III REVIVE-1 and REVIVE-2 trials to treat ABSSSIs. Iclaprim met both trials' primary endpoint of non-inferiority to vancomycin in early clinical response (see "Motif's Iclaprim Meets in Second Phase III for ABSSSIS")...