FDA Approves Injectafer® Single Dose Option for Iron Deficiency Anemia

Injectafer® (ferric carboxymaltose injection) has received approval by the FDA for a single dose option for the treatment of adult patients with Iron Deficiency Anemia (IDA). For patients weighing 50 kg (110 lb) or more, Injectafer may now be administered as a 1000 mg single dose for IDA treatment.

Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, reported that Injectafer® (ferric carboxymaltose injection), an iron substitute medication, has been licensed by the Food and Drug Administration (FDA) for the treatment of Iron Deficiency Anemia (IDA) in adult patients who have intolerance to oral iron, have had an unsatisfactory response to oral iron, or have non-dialysis dependent chronic kidney disease (CKD).

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. 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.”

The FDA first approved Injectafer in 2013 as a 1500 mg treatment course, given in two doses of up to 750 mg each separated by seven days.

The 1500 mg regimen, given in two doses at least seven days apart, is the recommended dosage for patients weighing 50 kg (110 lb) or more. For adult patients with IDA, this dosage remains the most effective course of treatment for complete iron repletion.

The Injectafers’ safety and efficiency as an IDA treatment have been assessed in four randomized, open-label, controlled clinical trials. In Trials 1 and 2, Injectafer was given at a dosage 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, for a total dose of 1500 mg of iron, to assess protection and efficacy. Injectafer 15 mg/kg to a maximum of 1000 mg was given as a single dose per course in Trials 3 and 4 to assess protection and tolerability in patients weighing 50 kg or more.

Injectafer has been tested in over 40 clinical trials involving over 8,800 patients from all over the world. Since its initial authorisation by the European Union (EU) in 2007, Injectafer has been approved in 75 countries, and it is the most studied intravenous drug in the world. Injectafer’s single 1000 mg dosage option is expected to be available in the coming weeks, according to Daiichi Sankyo, Inc.

About Injectafer®

Injectafer® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-dialysis dependent chronic kidney disease.

Injectafer® (ferric carboxymaltose injection), acting as an iron substituting medication, is administered intravenously (into a vein) by a healthcare provider. Injectafer is given in two 750 mg doses separated by at least 7 days for patients weighing 50 kg (110 lb) or more, for a total average dose of 1500 mg of iron per course. Each dosage is 15 mg/kg body weight for patients who weigh less than 50 kg (110 lb). Injectafer can also be given as a single 1000 mg dose to patients who weigh more than 50 kg (110 lb).

Outside of North America, Vifor Pharma (Switzerland) manufactures and distributes Injectafer under the brand Ferinject® (Ferric Carboxymaltose).

About American Regent, Inc.

American Regent, Inc., a Daiichi Sankyo Group company, is a top-10 injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables for healthcare providers. For nearly 20 years, we have been a leader in IV iron therapy. American Regent is committed to U.S.-based manufacturing. In 2018, more than 99% of units supplied were formulated, filled, and finished at our U.S.-based facilities, making the company uniquely positioned to quickly mobilize to respond to shortages or changes in market needs.

For more information, please visit www.americanregent.com.

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