KIT-302Treatment for Hypertension, Osteoarthritis
Kitov Updates on KIT-302 New Drug Application
TEL AVIV, Israel, June 26, 2017 /PRNewswire/ -- Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV), an innovative biopharmaceutical company, announced today that it has begun the process of digitizing its New Drug Application (NDA) for KIT-302, its lead drug candidate, through Parexel International Corporation, a clinical research organization, which has been engaged by Kitov for the preparation of the NDA into the standard, accepted electronic format of the U.S. Food and Drug Administration (FDA). KIT-302 is Kitov's patented combination of celecoxib and amlodipine, is intended to treat osteoarthritis pain and hypertension simultaneously.
In accordance with the FDA's usual practice, within 60 days of its receipt of the electronic submission of the complete set of NDA modules, the FDA is expected to determine whether the NDA is complete and acceptable for filing. As such, Kitov expects that the formal filing of the NDA by the FDA will occur by the end of the third quarter of 2017.
"While we experienced unexpected delays in the provision of certain technical documentation from external service providers, we are pleased with the quality of our NDA submission modules, and we expect the FDA to complete its review and filing of the NDA within the standard 60 days" stated J. Paul Waymack, M.D., Sc.D., Kitov's Chairman of the Board and Chief Medical Officer. Dr. Waymack added, "We are still on track to meet our anticipated Prescription Drug User Fee Act (PDUFA) date with FDA approval for marketing of KIT-302, during the second quarter of 2018. The data in KIT-302's pivotal Phase III clinical trial were generated, collected, validated and analyzed by leading independent clinical research organizations and service providers, and demonstrated that the Phase III study of KIT-302 met its primary endpoint with statistical significance of 0.001. Given the excellent results of our Phase III clinical trial we are confident that KIT-302 will be approved by the FDA and become a successful treatment for osteoarthritis and hypertension."
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, KIT-302, intended to treat osteoarthritis pain and hypertension simultaneously, achieved the primary efficacy endpoint for its Phase III clinical trial. 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 Holdings Ltd.
Posted: June 2017
- Kitov Announces Filing by FDA of New Drug Application for KIT-302 - October 2, 2017
- Kitov Submits New Drug Application to FDA for KIT-302 - July 31, 2017