Motif Bio Announces FDA Acceptance of New Drug Application with Priority Review for Iclaprim for Treatment of Acute Bacterial Skin and Skin Structure Infections

August 14, 2018
Motif Bio plc

Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the U.S. Food & Drug Administration (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.

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