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

Motif Bio plc announced the initiation of a 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). The NDA submission is expected to be completed during the second quarter of 2018.

Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA together with Fast Track Designation. A candidate granted Fast Track Designation is eligible for a rolling NDA submission, which means that a company can submit completed sections of its NDA, rather than waiting until every section of the NDA has been finalised. Upon acceptance for filing by the FDA of a complete NDA, iclaprim will receive Priority Review status which will result in a review period of up to six months. Upon NDA approval as a new chemical entity with QIDP designation, iclaprim will be eligible for 10 years of market exclusivity in the U.S. starting from the date of first approval.