Published Date : Jan 28, 2014
The US Food and Drug Administration (FDA) have issued a full drafted response letter for the supplemental new drug application (sNDA) in the market. This new drug is for the AMAG Pharmaceuticals’ Feraheme (ferumoxytol) injection that is useful for the intravenous (IV) use.
This new drug – sNDA is aimed at intensifying the indication of the Feraheme beyond all the existing chronic kidney disease (CKD). This helps to include all the adult iron deficiency anemia (IDA) patients that have been tolerated or have failed the oral iron treatment.
However, the FDA letter stated that the AMAG has not provided any sufficient information to authorize the labeling of Feraheme for effective and safe use of a specific proposed period of indication. The regulatory agency further said that its decision was based on the collective ferumoxytol data that also included the global Phase III IDA program and global post-marketing safety reports.
FDA\'s suggestion to AMAG was to generate the additional clinical trial data with substantial primary composite safety endpoint in case of serious cardiovascular events, hypersensitivity/anaphylaxis and death. FDA also managed to propose potentially effective and evaluating alternative dosing of Feraheme.
As of now, the company is assessing all the recommendations and content of the letter and its future plans in order to further discuss it with the FDA. AMAG Pharmaceuticals believes that the approval of the Feraheme sNDA would cater the physicians with extremely important treatment options to cure the patients with IDA and all those people who have failed or could not tolerate the oral iron content in the body, said Steve Caffe – the chief development and regulatory officer of AMAG Pharmaceuticals. He also added that, the upcoming weeks for the company will be completely involved in working with the FDA to determine the ultimate solution and regulatory path for Feraheme in the IDA patient population market.