NEW YORK, June 14, 2018 (GLOBE NEWSWIRE) — Motif Bio plc (AIM:MTFB) (NASDAQ:MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
“The NDA submission for iclaprim is a major milestone for Motif Bio. Our team of experts has worked tirelessly to achieve this important goal,” said Graham Lumsden, Chief Executive Officer. “We look forward to working with the FDA with the goal of bringing this antibiotic candidate to patients as expeditiously as possible.”
Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA together with Fast Track Designation. Upon acceptance of the filing of the NDA by the FDA, iclaprim will receive Priority Review, a review period of six months instead of the standard ten months. If iclaprim is approved as a new chemical entity with QIDP designation, it will be eligible for 10 years of market exclusivity in the U.S. starting from the date of approval.Press release Hemex is proud to have contributed to this major achievement for Motif Bio!