Rockwell Medical Submits Supplemental Data to FDA for IND Application for Phase 2 FPC Home Infusion Trial
Home Infusion, where various medications are given via infusion therapy in the home, rather than an infusion center, is a rapidly-growing segment of home healthcare. Many patients that are receiving infusion therapy at home suffer from diseases that are associated with iron deficiency, which is difficult to treat with traditional forms of iron.
"We are pleased to provide the FDA with the additional data it requested to support our IND for FPC in patients undergoing infusion therapy at home," said
The FDA has 30 days to review the additional data that have been submitted. In the event that the FDA has no further questions or requirements regarding the submission, the Company would expect the trial to start shortly after the review period ends.
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 life-saving hemodialysis concentrate products to kidney dialysis clinics in the
Home health is an area of medicine experiencing explosive growth – a trend that will likely continue over the next decade due to an aging US population, the need to control costs, the desire to improve patient outcomes, and the convenience of home healthcare.
Home infusion therapy, an important part of some home care regimens, allows patients with diseases requiring regular infusions of intravenous medications to be treated in the comfort of their home and has been proven to be a cost-effective, safe, and efficacious alternative to inpatient care for a variety of therapies and disease states, both acute and chronic.
Treating IDA as part of an existing home infusion regimen more effectively, calls for an innovative approach.
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as, "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "can," "would," "develop," "plan," "potential," "predict," "forecast," "project," "intend" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in
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