Clinical-stage biopharmaceutical company, Motif Bio, has received acceptance from the US Food and Drug Administration (FDA) for the filing of its new drug application (NDA) for iclaprim to treat acute bacterial skin and skin structure infections (ABSSSI).
Approval
This acceptance indicates that the FDA has deemed the application sufficiently complete to perform a substantive review. The NDA has been granted priority review and a target decision date of 13 February 2019 has been set out by the FDA under the Prescription Drug User Fee Act (PDUFA).
“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,” stated Graham Lumsden, chief executive officer of Motif Bio. “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.”
Data from two Phase III trials (REVIVE-1 and REVIVE-2) evaluating iclaprim for the treatment of patients with ABSSSI, were included in the NDA. In both trials, iclaprim achieved the primary endpoint of non-inferiority (NI) (10% margin) compared to vancomycin, the current standard of care, at the early time point (ETP), 48 to 72 hours after the start of administration of the study drug, in the intent-to-treat (ITT) patient population. Additionally, the therapy achieved NI (10% margin) at the test of cure endpoint, 7 to 14 days after study drug discontinuation, in the ITT patient population.
Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA and if approved as a new chemical entity with QIDP designation, it will be eligible for 10 years of market exclusivity in the US from the date of approval.