Motif Bio plc completes rolling submission to FDA for iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Motif Bio plc has announced the completion of its rolling submission of a New Drug Application (NDA) to the FDA for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

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.