FDA Approval of Injectafer®

The U.S. Food and Drug Administration (FDA) has recently approved a single 1000 mg dose option of Injectafer® (ferric carboxymaltose injection), an iron replacement product, for the treatment of iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron, have had unsatisfactory response to oral iron, or have non-dialysis dependent chronic kidney disease (CKD).

In the updated supplemental New Drug Application (sNDA) for Injectafer®, the experts stated, "For patients weighing 50 kg or more, Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single dose treatment course."

Injectafer was previously approved by the FDA in 2013 with a dosage regimen of 750 mg IV in 2 doses separated by at least 7 days in patients weighing at least 50kg for a total cumulative dose of 1500 mg. The recent updation was based on the 2 randomized, open-label, controlled clinical trials that evaluated the safety and tolerability of Injectafer as a single dose treatment course administered as 15mg/kg to a maximum of 1000 mg in patients weighing at least 50kg.

Linda Mundy, Chief Medical Officer at American Regent, Inc. said, "We are pleased to build on the proven, mainstay Injectafer 1500 mg two-dose course of treatment with the approval of this new 1000 mg single dose option." She further added, "More than 1.7 million patients have been treated with Injectafer in the U.S. and healthcare providers now have an additional dosing option for adult patients with IDA who may not be appropriate for oral iron or who have non-dialysis dependent CKD."

Injectafer® (ferric carboxymaltose injection) is an iron replacement product for the treatment of iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-dialysis dependent chronic kidney disease. Injectafer® is the most studied IV iron therapy with more than 40 clinical trials with >8800 patients treated worldwide. It is, so far, approved in 83 countries since its initial EU approval in 2007.

Daiichi Sankyo, Inc. anticipates the single 1000 mg dose option of Injectafer will be available in the coming weeks.