The US Food and Drug Administration (FDA) has approved ferric carboxymaltose injection (Injectafer) for the treatment of iron-deficiency anemia (IDA) in adults who either cannot tolerate or have not responded well to oral iron.
Injectafer, made by American Regent Inc, a division of Luitpold Pharmaceuticals Inc, is also indicated for the treatment of IDA in adult patients with nondialysis dependent chronic kidney disease, the company said.
According to the company, 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 United States have IDA. Current therapies are either 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.
With ferric carboxymaltose injection, a single dose of up to 750 mg can be administered undiluted as an intravenous push injection at a rate of 100 mg/minute or as an intravenous infusion in up to 250 mL 0.9% sodium chloride injection over the course of at least 15 minutes, the company says.
The safety and efficacy of ferric carboxymaltose injection for treatment of IDA were evaluated in 2 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 2 occasions separated by at least 7 days up to a maximum cumulative dose of 1500 mg of iron.
"The inclusion/exclusion criteria for both studies allowed patients with various comorbidities, characteristic of this broad patient population," the company notes in a news release. "Additionally, patients with a history of drug allergies were included in the trials, providing robust safety data in this difficult to treat subset of patients."
The entire Injectafer program consisted of more than 11,071 patients treated with either the drug or a comparator. "This represents the largest safety database ever submitted to the FDA to support the approval of an [intravenous] iron product," the company says.
Outside of North America, the drug is manufactured and marketed under the name of Ferinject (Ferric Carboxymaltose) by Vifor Pharma. Ferinject is currently registered in 46 countries and is marketed in 37 countries worldwide.
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Cite this: FDA Approves Injectafer for Iron Deficiency Anemia - Medscape - Aug 01, 2013.