Business
Rockwell Medical, Inc. Files Pre-IND Meeting Request with FDA for its Proposed Clinical Trial of FPC as a Treatment for Iron Deficiency Anemia in Patients Receiving Home Infusion
WIXOM, Mich., June 28, 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., June 28, 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 a pre-IND (Investigational New Drug) meeting request 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. For example, it is estimated that 40%-55% of all home parenteral nutrition patients are iron deficient. 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, such as, poor immune function and heart failure. “This is an important step for Rockwell Medical and home infusion patients as we believe that FPC is uniquely suited to address this important unmet clinical need,” said Russell Ellison, M.D., President and Chief Executive Officer of Rockwell Medical. “We expect to finalize our Phase 2 clinical study design and protocol with the advice and guidance of the FDA.” 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. The Company is developing FPC for the treatment of iron deficiency in patients outside of dialysis, who are receiving intravenous medications in the home infusion setting, a large and rapidly growing segment of healthcare, and where these patients suffer from chronic diseases ass...