Drug news
NDA application to FDA of iclaprim to treat acute bacterial skin and skin structure infections is delayed to second quarter of 2018.-Motif Bio plc.
Motif Bio plc a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, provided an update on the status and timeline for submission of its New Drug Application (NDA) to the FDA for its targeted, Gram-positive investigational antibiotic, iclaprim, for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
In consultation with its advisers, the Company has decided that in order to ensure a complete and high quality submission, it would be prudent to take additional time and consequently, the Company now expects that the NDA will be submitted to the FDA during the second quarter of 2018.