LEXINGTON, Mass.—Health Canada, on Dec. 8 granted marketing approval to AMAG Pharmaceuticals and Takeda Canada for the iron drug Feraheme.
The approval is for Feraheme (ferumoxytol) Injection for intravenous (IV) use as an iron replacement therapy for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD).
According to Health Canada, the government department that oversees Canada's public health, approximately 1.9 to 2.3 million people are living with CKD, many with iron deficiency anemia.
Under an agreement with AMAG, Takeda has an exclusive license to market Feraheme for all therapeutic applications in Canada. Upon the first commercial sale of Feraheme in Canada, AMAG will receive a milestone payment of $3 million.
“The approval of Feraheme by Health Canada is an important milestone for AMAG and our efforts to expand its reach to new geographies and broader patient populations,” said Frank E. Thomas, chief operating officer and interim president and chief executive officer of AMAG. “To that end, we have marketing applications for ferumoxytol to treat IDA in adult CKD patients currently under review in other regions, including Europe. Additionally, we plan to complete enrollment in a global registration program for the broader indication of iron deficiency anemia in early 2012, which will be the basis for global regulatory filings to expand the indication beyond CKD.”
Feraheme has been available in the United States for more than two years. In Canada, Feraheme will be administered in two 510 mg IV injections two to eight days apart. The two 510 mg doses can be delivered in under 1 minute each, according to AMAG.
“We are pleased that this approval will provide an effective new treatment option for adults in Canada living with iron deficiency anemia related to their chronic kidney disease,” said Mike Egli, General Manager, Takeda Canada, Inc. “We are poised to maximize Feraheme’s entry into Canada and are pleased to be able to provide this new treatment option to patients.”
