First and only high-dose intravenous iron for iron deficiency anemia of various etiologies
American Regent, Inc., a subsidiary of Luitpold Pharmaceuticals, Inc. (a Daiichi Sankyo Group Company), announced today an expanded promotional campaign for Injectafer (ferric carboxymaltose injection) in the United States. It is also announcing that Injectafer has received a C code (C9441), which will allow health care providers to be reimbursed for administering Injectafer to Medicare patients in the outpatient hospital setting. Injectafer is the first high-dose, non-dextran intravenous (IV) iron for the treatment of adult patients with iron deficiency anemia (IDA) of various etiologies who have intolerance to oral iron or who have had an unsatisfactory response to oral iron. It is also indicated for treatment of IDA in adult patients who have non-dialysis dependent chronic kidney disease. With the US launch of Injectafer, ferric carboxymaltose (the active ingredient) is now approved in more than 50 countries.
Injectafer® Ferric Carboxymaltose Injection (Photo: Business Wire)
The new promotional campaign will feature full-scale detailed journal advertisements, detail pieces and other promotional materials developed after receipt of regulatory review comments. They will replace the initial launch materials and will enable American Regent to provide physicians with more complete information about the key features relating to the safety and efficacy of Injectafer
"We are pleased to have received the new C code for Injectafer, which gives Medicare patients greater access to this high-dose iron product. One of the great advantages of Injectafer is that it allows clinicians to safely administer more iron in fewer infusions and over a shorter time period compared to standard intravenous iron products, with the outcome of greater iron repletion in more patients," commented Jacalyn Beltrani, MBA, Vice President of Commercial Operations of American Regent, Inc. "Injectafer also does not interfere with important clinical imaging tests such as MRI, which is especially significant for certain patient groups who require such tests for diagnosis, surgical planning or treatment monitoring."
In the pivotal clinical trialsi,ii, two doses of Injectafer (up to 750 mg each, or a total cumulative dose of up to 1500 mg) provided greater increases in hemoglobin and iron indices compared to both oral iron and IV standard of care iron therapies, which are administered over more visits and at lower single and total cumulative doses (up to approximately 1000 mg). In addition, a significantly higher proportion of patients who received Injectafer achieved a hemoglobin of >12 g/dL during the course of treatment compared to both oral iron (a 27.9 percent difference) and standard IV irons (a 26.1 percent difference).
"Injectafer (ferric carboxymaltose injection) is an important clinical advance for many patients with iron deficiency anemia," said principal investigator Jane E. Onken, MD, of Duke Clinical Research Institute, Durham, North Carolina. "Patients in the pivotal studies who received the drug had early and sustained responses. The proportion of patients who achieved clinically meaningful increases in hemoglobin was significantly greater in the groups that received ferric carboxymaltose than in the groups who received oral iron or standard IV therapies. Furthermore, there were significant mean changes in hemoglobin and all other iron indices measured in the ferric carboxymaltose subjects compared with the oral iron and standard IV iron groups."
Injectafer was approved by the FDA in July 2013 for the treatment of IDA in adult patients who have intolerance to oral iron, who have had an unsatisfactory response to oral iron, or who have non-dialysis dependent chronic kidney disease. The drug can be administered as a single dose of up to 750 mg by IV push injection or 15-minute infusion, and can be followed by a second dose 7 days later for a total cumulative dose of up to 1500 mg of iron per treatment course. The majority of patients (93 to 95 percent) in Injectafer trials received the target dose of 1500 mg. Injectafer is not a contrast agent and does not interfere with magnetic resonance imaging (MRI) tests.
In addition to the new C code (C9441; Medicare-only hospital outpatient settings), Injectafer is also reimbursable using J code J3490 for delivery in physician offices and non-Medicare outpatient settings. The full prescribing information for Injectafer is available at: http://www.injectafer.com/files/Prescribing_Information.pdf.
About Iron Deficiency Anemia
There are over 7.5 million people in the US with iron deficiency anemia (IDA), a condition that occurs when body iron stores are inadequate for normal red blood cell production. Fatigue, difficulty concentrating, shortness of breath, and dizziness are common symptoms, significantly impacting patients' quality of life. IDA is a common complication of many diseases and conditions, including cancer, chronic kidney disease, gastrointestinal conditions, obstetric and gynecological conditions and congestive heart failure. It affects over one-third of inflammatory bowel disease patients and nearly one-quarter of patients who have undergone gastric bypass surgery. IDA is prevalent in women, affecting over 3 million US women of childbearing age due to conditions such as heavy uterine bleeding, postpartum anemia, and pregnancy. Blood disease expert, Dr. Lawrence Goodnough, and Lynell D'Sylva from American Regent recently discussed the importance of maintaining sufficient iron levels on Lifetime's special, The Balancing Act. The full segment can be viewed here.
About Injectafer
Injectafer (ferric carboxymaltose injection) is the first non-dextran intravenous (IV) iron approved for the treatment of adult patients with iron deficiency anemia (IDA) of various etiologies who are intolerant to or who have had an unsatisfactory response to oral iron, in addition to use in non-dialysis dependent chronic kidney disease (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 sodium chloride injection, USP, over at least 15 minutes.
The safety and efficacy of Injectafer for treatment of iron deficiency anemia 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 compared two 750 mg doses of Injectafer (ferric carboxymaltose injection) to either oral or IV iron (standard of care therapy) in patients with iron deficiency anemia of various etiologies and included approximately 1000 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). In addition, a significantly higher proportion of patients who received Injectafer achieved a hemoglobin of >12 g/dL during the course of treatment compared to both oral iron (57.0% vs. 29.1%, respectively) and IV standard of care (50.6% vs. 24.5%, respectively) (p=0.001 for both). 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.
Trial 2, the largest head-to-head study of IV iron in high risk patients with iron deficiency anemia and CKD, compared Injectafer to Venofer (iron sucrose injection, USP; American Regent, Inc., Shirley, NY) and included 2561 patients, approximately half of whom received Injectafer. In these high risk patients, two 750 mg doses of Injectafer increased hemoglobin more than five 200 mg 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
Injectafer is manufactured and marketed under the name of Ferinject (ferric carboxymaltose) by Vifor Pharma (Switzerland) outside of North America.
IMPORTANT SAFETY INFORMATION
INDICATIONS/CONTRAINDICATIONS
Injectafer (ferric carboxymaltose injection) is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, and in adult patients with non-dialysis dependent chronic kidney disease. Injectafer is contraindicated in patients with hypersensitivity to Injectafer or any of its inactive components.
WARNINGS AND PRECAUTIONS
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Injectafer. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Injectafer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Injectafer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer® (ferric carboxymaltose injection). Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but were not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1775) of these subjects.
In clinical studies, hypertension was reported in 3.8% (67/1775) of subjects. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Injectafer administration.
In the 24 hours following administration of Injectafer, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Injectafer
ADVERSE REACTIONS
In two randomized clinical studies, a total of 1775 patients were exposed to Injectafer, 15 mg/kg of body weight, up to a single maximum 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. Adverse reactions reported by =2% of Injectafer-treated patients were nausea (7.2%); hypertension (3.8%); flushing/hot flush (3.6%); blood phosphorus decrease (2.1%); and dizziness (2.0%).
The following serious adverse reactions have been most commonly reported from the post-marketing spontaneous reports: urticaria, dyspnea, pruritus, tachycardia, erythema, pyrexia, chest discomfort, chills, angioedema, back pain, arthralgia, and syncope.
See full prescribing information at www.injectafer.com
About American Regent
American Regent, Inc., a wholly owned subsidiary of Luitpold Pharmaceuticals, Inc. (a Daiichi Sankyo Group Company), headquartered in Shirley, NY, distributes over 80 pharmaceutical products, including Venofer (iron sucrose injection, USP), the #1 selling intravenous iron therapy in the United States. For more information, please visit www.americanregent.com.
About Luitpold Pharmaceuticals, Inc.
Luitpold Pharmaceuticals, Inc., a Daiichi Sankyo Group Company headquartered in Shirley, NY, manufactures over 80 pharmaceutical products, including Venofer (iron sucrose injection, USP), the 1 selling intravenous iron therapy in the US, which are distributed through its human health subsidiary, American Regent, Inc. Luitpold Pharmaceuticals, also markets dental bone regeneration products and veterinary pharmaceuticals through its Osteohealth and Animal Health divisions, respectively. For more information on Luitpold or any of its divisions, please visit: www.luitpold.com.
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has created a "Hybrid Business Model," which will respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit: www.daiichisankyo.com.
About Vifor Pharma
Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world. For more information about Vifor Pharma and its parent company Galenica, please visit www.viforpharma.com and www.galenica.com.
Venofer and Injectafer are manufactured under license from and are registered trademarks of Vifor (International) Inc., Switzerland.
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i Onken JE, Bregman DB, Harrington RA, et al. Ferric carboxymaltose in patients with iron-deficiency anemia and impaired renal function: the REPAIR-IDA trial. Nephrol Dial Transplant. 2013 Aug 20. [Epub ahead of print].
ii Onken JE, Bregman DB, Harrington RA, et al. A multicenter, randomized, active-controlled study to investigate the efficacy and safety of intravenous ferric carboxymaltose in patients with iron deficiency anemia. Transfusion. 2013. doi: 10.1111/trf.12289. [Epub ahead of print].
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