FDA Approves Single Dose Ferric Carboxymaltose Injection Treatment

The US Food and Drug Administration (FDA) has approved a new single 1000 mg dose of ferric carboxymaltose injection (Injectafer).

The drug is an iron replacement product for the treatment of iron deficiency anemia (IDA) in adult patients with oral iron intolerance, unsatisfactory response to oral iron, or a non-dialysis dependent chronic kidney disease.

The approval was granted to Daiichi Sankyo, Inc and American Regent, Inc.

The Drug

Ferric carboxymaltose injection treatment was first approved in 2013 by the FDA as a 1500 mg course. The drug was administered as 2 doses up to 750 mg, each dose separated by 7 days.

This dosage is recommended for patients weighing 50 kg (110 lb) or more.

Data show the dosage is the proven treatment course for evidence-based full iron repletion in adult patients with IDA.

A total of 4 randomized, open label, controlled clinical trials evaluated the safety and efficacy of ferric carboxymaltose injection for treatment of IDA.

Over trial 1 and 2, It was administered at a dose of 15mg/kg body weight up to a maximum single dose of 750 mg, on two separate occasions over 7 days, up to 1500 mg.

Then, in trial 3 and 4, for patients weighing 50 kg (100 lb) or more, ferric carboxymaltose injection at 15mg/kg for a maximum of 1000 mg was administered as a single dose per course.

Over 40 clinical trials have studied the therapy and it is approved in 75 countries since the European Union approval in 2007.

Reaction

In a statement, Linda Mundy, Chief Medical Officer at American Regent, Inc, said they were pleased with the new approval from the FDA.

"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," said Linda Mundy, MD, PhD, Chief Medical Officer at American Regent, Inc.

She went on to call the therapy an additional option for patients who may not be adherent to other treatments.

"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,” Mundy said."

The 1000 mg dose of ferric carboxymaltose injection is expected to become available in the next coming weeks.