Rockwell Medical Receives Important Feedback From FDA on
WIXOM, Mich., December 14, 2021 (GLOBE NEWSWIRE) – Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company dedicated to transforming iron deficiency treatment and anemia management and improved patient outcomes around the world, today announced that it has received comments from the U.S. Food and Drug Administration (FDA) regarding its investigational new drug (IND) application in support of its proposed d Ferric Pyrophosphate Citrate (FPC) Phase 2 clinical trial designed for the treatment of iron deficiency anemia and hemoglobin maintenance in patients receiving home infusion therapy.
âWe are breaking new ground with this study, which is the first of its kind, evaluating the use of parenteral iron in the treatment of iron deficiency anemia as part of the rapidly growing home infusion. The study proposal includes a new dosing regimen, adjusted to match the preferences of caregivers and patients receiving health care at home. We are working closely with the FDA to ensure that our planned approach is well suited to this patient population, âsaid Russell Ellison, MD, president and CEO of Rockwell Medical.
The FDA has requested that additional data relating to the microbiology and short-term stability of FPC be submitted to further support the method of drug administration proposed for the study. The company plans to conduct these additional studies, complete the required analysis, and provide the requested data in the first half of 2022. âWe have a clear understanding of the FDA’s request, and we believe there is a way forward. well defined towards generating the data. The effort will help us refine our study approach, which is carefully designed for the home infusion application. We expect these activities to have minimal impact on our planned dosing schedule for the first patient in this study, âsaid Marc Hoffman, MD, medical director of Rockwell Medical.
âThis important feedback from the FDA reinforces our confidence in the potential value of this therapy. We work to ensure that this product is designed taking into account the preferences of the patient and the caregiver. The ultimate success of our project would mean that patients will have access to treatment for iron deficiency anemia at home, so that they can potentially avoid visits to an office or clinic to receive iron. We believe this may be a significant breakthrough in the management of chronic iron deficiency anemia patients who wish to avoid health facility visits and associated risks, âsaid Dr Ellison.
After additional data is submitted, Rockwell must wait 30 calendar days before treating patients in the clinical trial. During this time, the FDA has the opportunity to review the IND and the additional data submitted.
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 therapies approved by the FDA and indicated for patients on 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 drugs intravenously as part of the home infusion. Additionally, Rockwell Medical is one of the two leading suppliers of hemodialysis concentrates vital to kidney dialysis clinics in the United States. For more information, visit www.RockwellMed.com.
Rockwell Medical forward-looking statements
Certain statements in this press release, including, without limitation, statements relating to the timing of the completion of response activities, the impact of response activities on the timing of administration of the first patient of the The trial, and the way forward to resolve the FDA issues, may constitute “forward-looking statements” within the meaning of federal securities laws. Words such as “could”, “could”, “should”, “should”, “believe”, “expect”, “anticipate”, “estimate”, “continue”, “could”, “could” , “Could”, “,” “develop”, “plan”, “potential”, “predict”, “foresee”, “project”, “intend” or the negative of these terms, and expressions or statements Similar statements regarding intention, belief or current expectations, are forward-looking statements. Although Rockwell Medical believes that these forward-looking statements are reasonable, we should not place undue reliance on these forward-looking statements, which are based on information we believe in. available as of the date of this release. These forward-looking statements are based on current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical’s SEC records), many of which are outside the scope of of our control and subject to change. s could be significantly different. Risks and uncertainties include, but are not limited to: Rockwell’s ability to timely lift the clinical suspension of the planned home infusion trial, the impact of the COVID-19 pandemic on Rockwell’s business, including clinical trials, and FDA response time, the risks of current home infusion regimens for iron deficiency anemia, and whether the FDA will raise any further issues with IND over the course of time. of its examination period; and these risks discussed in more detail in the âRisk Factorsâ section of our quarterly report on Form 10-Q for the period ended September 30, 2021 and in our annual report on Form 10-K for the year ended December 31. 2020, as this description may be changed or updated in any future report we file with the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as required by law.
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