Rockwell Medical Announces Growth Plan and New Therapeutic Opportunities for Its Ferric Pyrophosphate Citrate (FPC) Platform - Seite 3
- Heart failure (HF) in the U.S. is a large and growing patient population. More than one million patients are hospitalized each year with acute decompensated heart failure, and iron deficiency (ID) is a common co-morbidity in all forms of HF.
- The acute heart failure (AHF) opportunity for FPC is associated with a large patient population with a high incidence of iron deficiency. FPC has theoretical acute clinical advantages (<30 days) vs. traditional IV iron therapy for iron deficient acute heart failure patients and could have an impact on hospital length of stay and/or 30-day readmissions.
- The majority of heart failure patients admitted to the hospital are insured by Medicare/Medicaid through a well-established universal approach usually resulting in a bundled reimbursement structure.
- Rockwell Medical intends to hold a Type C meeting with the FDA in the second half of 2021 to discuss a potential regulatory pathway. This meeting with the FDA will inform whether the Company ultimately pursues an indication in AHF.
An archived webcast of the call will be available under “Events & Presentations” in the Investor section of the Company’s website, https://ir.rockwellmed.com/.
About Rockwell Medical
Rockwell Medical is a biopharmaceutical company dedicated to transforming anemia management in a wide variety of therapeutic areas and across the globe, improving the lives of very sick patients. The Company’s initial focus is the treatment of anemia in end-stage kidney disease (ESKD). Rockwell Medical’s exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU (ferric pyrophosphate citrate injection), are the only FDA-approved therapeutics indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Rockwell Medical is also an established manufacturer, supplier and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad.
About Triferic Dialysate and Triferic AVNU
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Triferic Dialysate and Triferic AVNU are the only FDA-approved therapies in the U.S. indicated to replace iron and maintain hemoglobin in hemodialysis patients during each dialysis treatment. Triferic Dialysate and Triferic AVNU have a unique and differentiated mechanism of action, which has the potential to benefit patients and health care economics. Triferic Dialysate and Triferic AVNU represent a potential innovative medical advancement in hemodialysis patient iron management – with the potential to become the future standard of care.