The US Food and Drug Administration (FDA) has issued a complete response letter to AMAG Pharmaceuticals, Inc. 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 anaemia (IDA) patients who have failed or cannot tolerate oral iron treatment.
A complete response letter is a communication from the FDA that informs companies that an application cannot be approved in its present form. In the letter, the FDA stated that AMAG has not provided sufficient information to permit labelling 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 programme 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.
"We continue to believe that approval of the Feraheme sNDA would provide physicians with an important treatment option for patients with IDA, who have failed or could not tolerate oral iron," said Steve Caffé, chief development and regulatory officer of AMAG Pharmaceuticals. "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."
In the United States, Feraheme (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anaemia (IDA) in adult patients who have failed oral iron therapy. Feraheme received marketing approval from the US Food and Drug Administration (FDA) on June 30, 2009 for the treatment of IDA in adult chronic kidney disease patients and was commercially launched by AMAG in the US shortly thereafter.
Ferumoxytol is protected in the US by five issued patents covering the composition and dosage form of the product. Each issued patent is listed in the FDA's Orange Book. These patents are set to expire in 2020; a request for patent term extension has been filed, which, if granted, may extend the patent term to 2023 for one of the patents.
Ferumoxytol received marketing approval in Canada in December 2011, where it is marketed by Takeda as Feraheme, and in the European Union in June 2012 and Switzerland in August 2012, where it is marketed by Takeda as Rienso.
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that markets Feraheme (ferumoxytol) Injection and MuGard Mucoadhesive Oral Wound Rinse in the United States.