Rockwell Medical has provided an update on the status of the company's development of an intravenous formulation of the company's proprietary drug Triferic, which is the only FDA-approved therapy indicated to replace iron and maintain hemoglobin in adult hemodialysis patients with chronic kidney disease. The company is in the process of preparing a New Drug Application (NDA) for IV Triferic and anticipates that it will file the NDA in the fourth quarter of 2018, which would result in a Prescription Drug User Fee Act (PDUFA) action date in late 2019.
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"Based on feedback from a pre-NDA meeting with the FDA, we believe that we have an NDA package, including bioequivalence data, that would enable the FDA to review and act on this application before the end of 2019," said Stuart Paul, Rockwell Medical President and Chief Executive Officer. "We are excited about our planned NDA submission as it represents an important milestone in this process. The entire Rockwell Medical team is dedicated to maximizing the opportunity with IV Triferic, which has great potential to help patients both in the U.S. and abroad."
In addition, the company recently clarified and extended additional intellectual property (IP) rights related to IV Triferic, which, if approved, is expected to support the planned commercialization of this product. Details regarding the acquisition of these IP rights will be disclosed in a Current Report on Form 8-K, to be filed by the company.