Syngene Proposal To Conduct Phase I CT of Ferumoxytol Inj rejected by CDSCO panel
New Delhi: Stating that the proposal submitted by Syngene International could not be considered at present, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected the proposal to conduct the Phase I clinical trial of Ferumoxytol injection.
The drug to be used in the proposed trial is not of Indian origin, as the committee noted in highlighting the cause.
This came after Syngene International presented its proposal for the Phase I clinical trial of Ferumoxytol Injection (30 mg/mL) before the committee.
Ferumoxytol is an intravenous iron replacement product used to treat iron deficiency anaemia (IDA) in patients with chronic kidney disease (CKD) or in patients who are unable to tolerate or have not responded adequately to oral iron supplementation. It works by replenishing iron stores so that the body can make more red blood cells.
This drug is indicated for the treatment of iron deficiency anaemia in adult patients who have experienced intolerance to oral iron or have experienced an unsatisfactory response to oral iron or who have chronic kidney disease (CKD).
Ferumoxytol consists of superparamagnetic iron oxide coated with a carbohydrate shell consisting of branched polysaccharides, which helps to isolate bioactive iron from plasma components until the iron-carbohydrate complex enters macrophages in the reticuloendothelial system of the liver, spleen, and bone marrow.
At the recent SEC meeting for oncology and hemology held on March 14, 2023, the expert panel reviewed the proposal presented by Syngene International for the Phase-I clinical trial of Ferumoxytol Injection 30 mg/mL.
After detailed deliberation, the committee recommended that the proposal submitted by the firm could not be considered at present.
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