Posted by Michael Wonder on 14 Aug 2018
Motif Bio announces FDA acceptance of new drug application with priority review for iclaprim for treatment of acute bacterial skin and skin structure infections
14 August 2018 - PDUFA action date set for 13 February 2019.
Motif Bio today announced that the U.S. FDA has accepted for filing the new drug application for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
The application includes data from two Phase 3 trials (REVIVE-1 and REVIVE-2) evaluating iclaprim for the treatment of patients with ABSSSI.
