7:43AM AMAG Pharma is lower by 13% at 19.00 following news of complete response letter for the supplemental new drug application for Feraheme (ferumoxytol) injection for intravenous use (AMAG) 21.86 :
See 6:57 comment for details.
As mentioned, the FDA has issued a complete response letter for the supplemental new drug application for Feraheme (ferumoxytol) injection for intravenous use.
The FDA suggested that AMAG generate additional clinical trial data in the proposed broad IDA patient population with a primary composite safety endpoint of serious hypersensitivity/anaphylaxis, cardiovascular events, and death.
6:57AM AMAG Pharma announced the FDA has issued a complete response letter for the supplemental new drug application for Feraheme (ferumoxytol) injection for intravenous use; FDA suggested that AMAG generate additional clinical trial data in the proposed broad IDA patient population with a primary composite safety endpoint of serious hypersensitivity/anaphylaxis, cardiovascular events, and death (AMAG) 21.86 :
Co announced that the FDA has issued a complete response letter for the supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection for intravenous (IV) use. The sNDA sought to expand the indication for Feraheme beyond the current chronic kidney disease (CKD) indication to include all adult iron deficiency anemia (IDA) patients who have failed or cannot tolerate oral iron treatment.
In the letter, the FDA stated that AMAG has not provided sufficient information to permit labeling of Feraheme for safe and effective use for the proposed indication. The FDA indicated that its decision was based on the cumulative ferumoxytol data, including the global phase III IDA program and global post-marketing safety reports. The FDA suggested that AMAG generate additional clinical trial data in the proposed broad IDA patient population with a primary composite safety endpoint of serious hypersensitivity/anaphylaxis, cardiovascular events, and death. Additionally, the FDA proposed potentially evaluating alternative dosing and/or administration of Feraheme. AMAG is assessing the content and recommendations of the letter and plans further discussions with the FDA.
"In the coming weeks, we intend to work with the FDA to determine the best regulatory path for Feraheme in this broader IDA patient population."
Co will host a conference call and webcast today at 7:30 a.m. ET, during which management will discuss the complete response letter.
