The US Food & Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) by Motif Bio for iclaprim, which is a targeted, Gram-positive investigational antibiotic, indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
This implies that the FDA has determined that the application is suitable for a substantive review.
The NDA also has been granted Priority Review by the FDA.
The FDA has kept a target decision date of 13 February 2019 under the Prescription Drug User Fee Act (PDUFA).
Motif Bio chief executive officer Graham Lumsden said: “The NDA acceptance by the FDA is an important milestone for Motif Bio and reflects the dedication and commitment of our team who have worked tirelessly to accomplish this.
“We believe that, if approved, iclaprim could be an important new treatment option for patients with serious skin infections. We look forward to working closely with the FDA as we move through the review process with the goal of bringing iclaprim to patients as quickly as possible.”
More than 3.6 million patients with ABSSSI are reportedly hospitalised yearly in the US, of which up to 26% have renal impairment.
Hospitalised ABSSSI patients with obesity, diabetes and poor kidney function are vulnerable to vancomycin-associated kidney injury. Several standard of care Gram-positive antibiotics are not suitable for treatment of the patients with these conditions due to safety issues.
The NDA includes data from two Phase 3 trials (REVIVE-1 and REVIVE-2) analysing iclaprim for the treatment of patients with ABSSSI.
In both trials, iclaprim achieved the primary endpoint of non-inferiority, which is a 10% margin compared to vancomycin at the early time point of 48 to 72 hours after the start of administration of the study drug in the intent-to-treat patient population.
Iclaprim has already received Qualified Infectious Disease Product (QIDP) designation from the FDA.
Once approved as a new chemical entity with QIDP designation, iclaprim will be eligible for a decade of market in the US starting from the date of approval under the Generating Antibiotic Incentives Now Act (the GAIN Act).