July 1, 2015, Tel Aviv, Israel – Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage drug development, announced today that the FDA has approved the Company’s chemistry, manufacturing and controls (CMC) work plan following the successful conclusion of its pilot pharmacokinetics (PK) clinical study.
The approved work plan is for the development of a prototype of the final formulation of KIT-302, Kitov’s combination drug designed to treat osteoarthritis (OA) pain and hypertension (HTN) simultaneously. The plan includes stability testing for the final batches of the drug. Kitov expects to file a New Drug Application (NDA) with the FDA after eight months of stability testing.
About Kitov Pharmaceuticals
Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative biopharmaceutical company focused on late-stage drug development. 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 pipeline currently features two combination drugs intended to treat osteoarthritis (OA) pain and hypertension (HTN) simultaneously, including one that achieved the primary efficacy endpoint for its Phase III clinical trial. Lowering development risk and cost through fast-track regulatory approval of novel late-stage therapeutics, Kitov delivers rapid ROI and long-term potential to investors, while making a meaningful impact on people’s lives. For more information, visit www.kitovpharma.com.