American Regent Inc., a subsidiary of Luitpold Pharmaceuticals Inc., has received the US FDA approval for its Injectafer (ferric carboxymaltose injection), a parenteral iron replacement product used for the treatment of iron deficiency anaemia (IDA) in adult patients who have intolerance to oral iron or have had an unsatisfactory response to oral iron.

Injectafer is also indicated for iron deficiency anaemia in adult patients with non-dialysis dependent chronic kidney disease (NND-CKD).

“We are pleased with the FDA’s approval of Injectafer as the first high dose non-dextran IV iron indicated to treat adult patients with iron deficiency anemia in a broad patient population. Iron deficiency anaemia is a serious health condition which results in a diminished quality of life for those patients it afflicts. Current therapies are either limited to treating IDA in chronic kidney disease patients and/or require infusions over several hours or significant multiple dosing sessions. Now, with Injectafer, physicians can effectively and efficiently treat these patients with a single dose of up to 750 mg of iron via an IV push injection or over a 15 minute infusion followed by a second dose seven days later for a total treatment of up to 1500 mg of iron. This is a very important treatment advance for the correction of iron deficiency anaemia and we are very excited to be able to provide this new innovation to US physicians,” commented Mary Jane Helenek, R.Ph. MS, MBA, president and CEO of American Regent Inc.

IDA is a frequent complication in many GI disease states and conditions, affecting up to one-third of inflammatory bowel disease patients and up to 24 per cent of patients who have undergone gastric bypass surgery. It is also prevalent in children and women, with over 3 million US women of childbearing age affected due to conditions such as heavy uterine bleeding, postpartum anemia, and pregnancy.

Injectafer (ferric carboxymaltose injection) is the first non-dextran IV iron approved for the treatment of adult patients with IDA of various etiologies in addition to use in non-dialysis dependent CKD patients. A single dose of up to 750 mg of Injectafer can be administered undiluted as an IV push injection at a rate of 100 mg/minute or as an IV infusion in up to 250 mL 0.9 per cent Sodium Chloride Injection, USP, over at least 15 minutes.

The safety and efficacy of Injectafer for treatment of iron deficiency anaemia were evaluated in two clinical trials (Trial 1 and Trial 2) in which 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 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. 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.

Trial 1, the largest head-to-head study of IV iron in high risk patients with IDA and chronic kidney disease (CKD), compared Injectafer to Venofer (iron sucrose injection, USP). The study included 2,561 patients, approximately half of whom received Injectafer. In these high risk patients, two 750 mg doses of Injectafer raised hemoglobin more than five 200mg doses of Venofer, with a change in hemoglobin of 1.13 g/dL for Injectafer vs. 0.92 for Venofer. These increases were statistically significant (treatment difference [95% CI] = 0.21 [0.13, 0.28]). Rates of the adjudicated composite safety endpoint comprised of death, myocardial infarction, stroke, unstable angina, congestive heart failure, arrhythmias, hypertension and hypotension were statistically similar at 13.71% for Injectafer vs. 12.14% for Venofer (treatment difference [95% CI] = 1.57% [-1.10%, 4.25%]). Rates of a composite of death, myocardial infarction and stroke were 1.88% for Injectafer vs. 2.72% for Venofer.

Trial 2 compared two 750 mg doses Injectafer to either oral or IV iron (standard of care therapy) in patients with iron deficiency anemia of various etiologies and included approximately 1,000 patients half of whom received Injectafer. In this trial, Injectafer raised hemoglobin more than oral iron or IV standard of care therapy, with a mean change in hemoglobin of 1.57 g/dL vs. 0.80 g/dL when compared to oral iron and      2.90 g/dL vs. 2.16 g/dL when compared with IV standard of care therapy. These increases were statistically significant (p=0.001). Further, cardiovascular safety was evaluated based on an adjudicated composite safety endpoint comprised of death, myocardial infarction, stroke, unstable angina, congestive heart failure, arrhythmias, hypertension and hypotension. Rates of the composite safety endpoint were 3.95% for Injectafer vs. 4.90% when compared to IV standard of care and at 2.85% for Injectafer vs. 1.58% when compared to oral iron.

The entire Injectafer programme consisted of over 11,071 patients treated with the study product or a comparator. This represents the largest safety database ever submitted to the FDA to support the approval of an IV iron product.

Injectafer is manufactured and marketed under the name of Ferinject (Ferric Carboxymaltose) by Vifor Pharma (Switzerland) outside of North America. Ferinject is currently registered in 46 countries and is marketed in 37 countries worldwide.

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