Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, today announced that the U.S. Food and Drug Administration (FDA) has 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 intolerance to oral iron, have had unsatisfactory response to oral iron, or have non-dialysis dependent chronic kidney disease (CKD).

"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, Chief Medical Officer at American Regent, Inc. "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 was first approved by the FDA in 2013 as a 1500 mg course of treatment, administered as two doses up to 750 mg each separated by seven days. The 1500 mg regimen is the recommended dosage for patients weighing 50 kg (110 lb) or more, administered in two doses separated by at least 7 days. This dosage remains the proven course of treatment for evidence-based full iron repletion available for adult patients with IDA.

The safety and efficacy of Injectafer for treatment of IDA were established in four randomized, open-label, controlled clinical trials. In Trial 1 and 2, evaluating safety and efficacy, Injectafer 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 cumulative dose of 1500 mg of iron. In Trial 3 and 4, evaluating safety and tolerability, for patients weighing 50 kg or more, Injectafer 15 mg/kg to a maximum of 1000 mg was administered as a single dose per course.

Injectafer has been studied in more than 40 clinical trials that included over 8,800 patients worldwide.2 Injectafer has been approved in 75 countries since initial European Union (EU) approval in 20073 and is the most extensively studied intravenous iron.

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

About Injectafer

Injectafer (ferric carboxymaltose injection) is an iron replacement product and is given intravenously (into the vein) by a healthcare provider. For patients weighing 50 kg (110 lb) or more, Injectafer is administered in two doses of 750 mg separated by at least 7 days for a total cumulative dose of 1500 mg of iron per course. For patients weighing less than 50 kg (110 lb), each dose is administered as 15 mg/kg body weight. Alternatively, for patients weighing 50 kg (110 lb) or more, Injectafer may be administered as a single 1000 mg dose.

Injectafer is manufactured and marketed under the name of Ferinject? (Ferric Carboxymaltose) by Vifor Pharma (Switzerland) outside of North America.

U.S. Important Safety Information for Injectafer

INDICATIONS

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.