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Rockwell Medical Submits Investigational New Drug Application with FDA for its Proposed Clinical Trial of FPC as a Treatment for Iron Deficiency Anemia in Patients Receiving Home Infusion
WIXOM, Mich., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company dedicated to transforming the treatment of
About this update from Rockwell Medical, Inc.
[{"type":"text","content":"WIXOM, Mich., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in support of its proposed Phase 2 clinical trial of Ferric Pyrophosphate Citrate (FPC), designed for the treatment of iron deficiency anemia and maintenance of hemoglobin in patients receiving infusion therapy in the home setting. “Home infusion represents a large and rapidly growing segment of healthcare. Many patient groups requiring home infusion therapies suffer from chronic diseases that are associated with a high incidence of iron deficiency and anemia,” said Marc Hoffman, M.D., Chief Medical Officer of Rockwell Medical. “Current treatment patterns can be inadequate for patients on home infusion therapy with iron deficiency anemia, causing them to suffer extreme fatigue, and can result in serious health risks.” “We are very pleased to have achieved another development milestone with the submission of this IND for our FPC home infusion program as we expand our efforts to develop FPC outside of dialysis,” said Russell Ellison, M.D., President and Chief Executive Officer of Rockwell Medical. Once the IND is submitted, a sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND. About Rockwell Medical Rockwell Medical is a commercial-stage biopharmaceutical company developing and commercializing its next-generation parenteral iron technology platform, Ferric Pyrophosphate Citrate (FPC), which has the potential to lead transformative treatments for iron deficiency in multiple disease states, reduce healthcare costs and improve patients’ lives. The Company has two FDA-approved therapies indicated for patients undergoing hemodialysis, which are the first two products developed from the FPC platform. Rockwell Medical is also advancing its FPC platform by developing FPC for the treatment of iron deficiency anemia in patients outside of dialysis, who are receiving intravenous medications in the home infusion setting. In addition, Rockwell Medical is one of two major suppliers of lif...