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Kitov Receives Pre-NDA Meeting Response From FDA for KIT-302, Supporting its NDA Submission

TEL-AVIV, Israel, May 12, 2015 /PRNewswire/ -- Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage drug development, today announced it has received, from the U.S. Food and Drug Administration (FDA), meeting minutes from its recent pre-New Drug Application meeting for KIT-302 . Based on the details of the FDA's response, Kitov is on track to submit the NDA for marketing approval of KIT-302 by the end of 2016.

The meeting, which took place on April 11, 2016, had been requested by Kitov to seek FDA concurrence that the NDA content will meet the agency's requirements for NDA submission.

The FDA confirmed that an Advisory Committee Review should not be required for the NDA review, and that the FDA may accept 6 months data of long term stability at the time of submission. Furthermore, based on the minutes, the Company will include additional information as part of the planned NDA submission, such as market data and a medical literature review on the use of amlodipine and celecoxib in animals. The FDA requested that the statistical calculation for the primary efficacy endpoint be performed using an alternate mathematical technique. This calculation was subsequently performed by Kitov and also demonstrates that KIT-302 met its primary efficacy endpoint.

"These minutes bring us closer to submitting an NDA to the FDA for KIT-302 via the 505(b)(2) path at the end 2016, as currently planned. This paves the way for potential regulatory approval in 2017," stated Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer.

A combination drug, KIT-302, simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. KIT-302 is comprised of two FDA...