Rockwell Medical Receives Important Feedback from FDA on its IND Application for Phase 2 Trial of Ferric Pyrophosphate Citrate in Home Infusion
“We are breaking new ground with this study, which is the first of its kind, evaluating the use of parenteral iron in treating iron deficiency anemia in the rapidly-growing home infusion setting. The study proposal includes a novel dosing regimen, one that is fine-tuned to match the preferences of caregivers and patients receiving health care at home. We are working closely with FDA to ensure that our planned approach is well suited for this patient population,” said
FDA requested that additional data related to the microbiology and short-term stability of FPC be submitted to further support the drug administration method proposed for the study. The company expects to run these additional studies, complete the required analysis, and provide the requested data in the first half of 2022. “We have a clear understanding of the request from FDA, and we believe there is a well-defined path forward to generate the data. The effort will help us refine our study approach, which is carefully designed for the home infusion application. We expect that these activities will have a minimal impact on the timing of our planned dosing of the first patient in this study,” said
“This important feedback from FDA strengthens our confidence in the potential value of this therapy. We are working to ensure that this product is studied with the patient and caregiver preferences in mind. The ultimate success of our project would mean patients will have access to a treatment for iron deficiency anemia in the home, so they could potentially avoid visits to an office or clinic to receive iron. We believe this may be a significant advance in the care of chronically ill patients with iron deficiency anemia who wish to avoid visits to healthcare facilities and the associated risks,” said
Once the additional data is submitted, Rockwell must wait 30 calendar days before treating any patients in the clinical trial. During this time, FDA has an opportunity to review the IND and the additional data that is submitted.
Rockwell Medical Forward-Looking Statements
Certain statements in this press release, including without limitation statements relating to the timing of completion of response activities, the impact of the response activities on the timing of dosing the first patient in the trial and the path forward to resolve the FDA’s questions, 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
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Source: Rockwell Medical, Inc.