Kitov Pharma (KTOV) Reports FDA Filing for New Drug Application for KIT-302

October 2, 2017 7:04 AM EDT
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Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV today announced that the U.S. Food and Drug Administration (FDA) filed the Company's New Drug Application (NDA) for KIT-302, its lead drug candidate, thereby accepting the NDA for a full review. KIT-302 is a patented combination of celecoxib and amlodipine, and is intended to treat osteoarthritis pain and hypertension simultaneously. In connection with its determination that Kitov's application is sufficiently complete to permit a substantive review, the FDA, under the Prescription Drug User Fee Act (PDUFA), has set a target date of May 31, 2018 to complete its review.

"The acceptance of filing of our NDA for KIT-302 represents a key achievement toward commercialization of our lead drug candidate. We intend to work closely with FDA as it reviews the NDA," stated J. Paul Waymack, M.D., Sc.D., Kitov's Chairman of the Board and Chief Medical Officer. "We look forward to FDA rendering a decision on approval for marketing of KIT-302 during the second quarter of 2018."

Dr. Waymack added, "We are extremely proud of the high-quality NDA package that has now been filed by FDA. We appreciate the hard work of our internal regulatory team in the preparation of NDA package, the participation of various clinics and hospitals in the United Kingdom in the trial, and the European Contract Research Organizations that collected, stored, and performed statistical analysis of the data. Most importantly, the data from KIT-302's pivotal Phase III clinical trial demonstrated that the study met its primary endpoint with statistical significance of p=0.001."



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