TEL AVIV, Israel, December 14, 2017 /PRNewswire/ --
Kitov Pharmaceuticals (NASDAQ: KTOV) (TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food & Drug Administration (FDA) has granted permission to Kitov to use the brand name Consensi™ for marketing KIT-302, subject to receipt of marketing approval from the FDA.
"The receipt of the FDA's permission to use Consensi as the brand name for our lead drug is another important step in executing on our corporate strategy and will facilitate the commercialization of KIT-302, once approved by the FDA, " stated J. Paul Waymack, M.D., Sc.D., Kitov's Chairman of the Board and Chief Medical Officer.
Consensi™ is a combination drug that is intended to simultaneously treat pain caused by osteoarthritis, as well as hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. Consensi™ is comprised of two FDA approved drugs, celecoxib (Celebrex®), a COX-2 inhibitor, for the treatment of pain caused by osteoarthritis, and amlodipine besylate (Norvasc®), a calcium channel blocker for lowering blood pressure.
In September 2017, the FDA filed Kitov's New Drug Application (NDA) for Consensi™ and, under the Prescription Drug User Fee Act (PDUFA), set a target date of May 31, 2018 to complete its review.
About Kitov Pharmaceuticals
Kitov Pharmaceuticals (NASDAQ: KTOV, TASE: KTOV) is an innovative biopharmaceutical drug development company. Leveraging deep regulatory and clinical-trial expertise, Kitov's veteran team of healthcare professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov's flagship combination drug, Consensi™ (previously referred to as KIT-302), intended to treat osteoarthritis pain and hypertension simultaneously, achieved the primary efficacy endpoints for its Phase III and Phase III/IV clinical trials. Kitov's newest drug, NT219, which is developed by its majority-owned subsidiary, TyrNovo Ltd., is a small molecule that presents a new concept in cancer therapy, and in combination with various approved oncology drugs, demonstrated potent anti-tumor effects and increased survival in various cancer models. By lowering development risk and cost through fast-track regulatory approval of novel therapeutics, Kitov plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people's lives. For more information on Kitov, the content of which is not part of this press release, please visit http://www.kitovpharma.com.
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SOURCE Kitov Pharmaceuticals