FDA accepts NDA for iclaprim to treat ABSSSI.- Motif Bio plc.

Motif Bio plc has announced that the FDA has accepted for filing the New Drug Application (NDA) for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections (ABSSSI). This means that the FDA has determined that the application is sufficiently complete to perform a substantive review. The NDA has been granted Priority Review, and the FDA has set a target decision date under the Prescription Drug User Fee Act (PDUFA) of February 13, 2019.

The NDA includes data from two Phase III trials (REVIVE-1 and REVIVE-2) evaluating iclaprim for the treatment of patients with ABSSSI. In both trials, iclaprim achieved the primary endpoint of non-inferiority (NI) (10% margin) compared to vancomycin, the current standard of care, at the early time point (ETP), 48 to 72 hours after the start of administration of the study drug, in the intent-to-treat (ITT) patient population. Iclaprim also achieved NI (10% margin) at the test of cure endpoint, 7 to 14 days after study drug discontinuation, in the ITT patient population.