FDA Approves Injectafer for Treatment of Iron Deficiency Anemia
First high-dose, nondextran IV iron for IDA (August 1)
The FDA has approved Injectafer (ferric carboxymaltose injection) for the treatment of iron-deficiency anemia (IDA) in adults who either cannot tolerate or have not responded well to oral iron.
Injectafer is also indicated for the treatment of IDA in adult patients with non–dialysis-dependent chronic kidney disease.
According to the product’s developer (American Regent, Inc.), the injection is the first high-dose, nondextran intravenous iron indicated for a “broad patient population” with IDA.
An estimated 7.5 million people in the U.S. have IDA. Current therapies are limited to treating IDA in patients with chronic kidney disease and/or require infusions over the course of several hours or significant multiple dosing sessions.
The safety and efficacy of Injectafer for the treatment of IDA were evaluated in two clinical trials in which the drug was administered at a dose of 15 mg/kg body weight up to a maximum single dose of 750 mg of iron on two occasions separated by at least 7 days, up to a maximum cumulative dose of 1,500 mg of iron.
The Injectafer development program consisted of more than 11,071 patients treated with either the drug or a comparator.