RE: sp13 Feb 2019 15:40
“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,” said 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.”
More than 3.6 million patients with ABSSSI are hospitalised annually in the U.S. It is estimated that up to 26% of hospitalised ABSSSI patients have renal impairment. Hospitalised patients with obesity, diabetes and/or poor kidney function are particularly vulnerable to vancomycin-associated kidney injury. Many standard of care Gram-positive antibiotics are not suitable for treatment of hospitalised ABSSSI patients with these conditions due to efficacy and/or safety issues.
The NDA includes data from two Phase 3 trials (REVIVE-1 and REVIVE-2) evaluating iclaprim for the treatment of patients with ABSSSI. 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. Iclaprim also 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. If iclaprim is approved as a new chemical entity with QIDP designation, it will be eligible for 10 years of market exclusivity in the U.S. starting from the date of approval, under the Generating Antibiotic Incentives Now Act (the GAIN Act).
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