Injectafer® receives US FDA approval for the treatment of Iron Deficiency Anaemia
Friday, 26 July 2013, ↓ directly to download
Injectafer® has received US Food and Drug Administration (FDA) approval for the treatment of Iron Deficiency Anaemia (IDA). Luitpold Pharmaceuticals, Inc., the US partner of Vifor Pharma, a company of the Galenica Group, will immediately launch the product. Injectafer® will be produced at the Luitpold manufacturing facility in Columbus, Ohio.
Injectafer® (US brand name of Ferinject®, ferric carboxymaltose) has received US Food and Drug Administration (FDA) approval for the treatment of Iron Deficiency Anaemia (IDA) in adult patients who have had an unsatisfactory response to oral iron or who have intolerance to oral iron.
Injectafer® is the first non-dextran intravenous iron therapy to gain US FDA approval for the treatment of IDA in a diverse group of patients with this debilitating condition, irrespective of the underlying origin. Injectafer® is also indicated for Iron Deficiency Anaemia in adult patients with non-dialysis dependent Chronic Kidney Disease (ND-CKD).
The approval is based on the evaluation of two large, multi-centre, randomised, controlled clinical trials conducted by Luitpold Pharmaceuticals, Inc. that studied more than 3,500 patients, of which approximately 1,800 were treated with Injectafer®. Both trials met their efficacy and safety endpoints and were presented at the American Society of Nephrology’s (ASN) Kidney Week 2011. The results of the VIT 31 study were recently published in the peer-reviewed journal “Transfusion”; results from the VIT 30 study (REPAIR-IDA trial) are anticipated to be published in another peer reviewed medical journal in the near future.
Luitpold Pharmaceuticals, Inc., the Vifor Pharma partner in the United States, will immediately launch Injectafer® to provide this important new drug to US physicians and their patients. In the US market, the product is available in 750mg vials and will be produced at the Luitpold manufacturing facility in Columbus, Ohio.
In the United States there are an estimated 7.5 million people with IDA, a condition that occurs when body iron stores are inadequate for normal red blood cell production. IDA is a frequent complication in many gastro-intestinal disease states and conditions, affecting up to one-third of inflammatory bowel disease patients, and up to 24% of patients undergoing bariatric 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 anaemia and pregnancy.
Ferinject® was approved by both the Swiss regulatory agency Swissmedic and the UK Medicines & Healthcare products Regulatory Agency (MHRA) in 2007. With the UK as Reference Member State, the MHRA has supported the subsequent approval of Ferinject® throughout the European Union. Ferinject® is currently registered for use in 46 countries and has been launched in 37 markets worldwide.
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.
Luitpold Pharmaceuticals, Inc., a Daiichi Sankyo Group Company, headquartered in Shirley, NY, US, manufactures over 80 pharmaceutical products including Venofer® (iron sucrose injection, USP), which are distributed through its human health subsidiary, American Regent, Inc.
For more information on Luitpold or any of its divisions and products, please visit: www.luitpold.com
Injectafer® (US brand name of Ferinject®) is an innovative non-dextran intravenous (i.v.) iron replacement therapy discovered and developed by Vifor Pharma, a company of the Galenica Group. Ferric carboxymaltose is the active pharmaceutical ingredient of Ferinject®. To date, Ferinject® (brand name of Injectafer® outside the US) has gained marketing authorisation in 46 countries worldwide for the treatment of iron deficiency where oral iron is ineffective or cannot be used. In many countries, intravenous iron replacement products are primarily used to treat dialysis patients. However, iron deficiency is also a complication of many other diseases. Vifor Pharma is evaluating new opportunities in the treatment of iron deficiency with Ferinject® in different therapeutic areas. Further clinical trials with Ferinject® in chronic kidney disease (CKD), oncology (anaemia in cancer patients), cardiology (chronic heart failure), patient blood management and women’s health are ongoing.
Iron Deficiency Anaemia (IDA) is a state in which iron stores are inadequate for normal blood formation, as the iron requirements exceed the supply. In severe cases red cells in a patient with IDA are both microcytic (small) and hypochromic (pale), and values for mean corpuscular volume (MCV) and mean corpuscular Hb concentration (MCHC) are characteristically reduced. According to the World Health Organization (WHO) it is estimated that about 700 million people have iron deficiency anaemia (IDA).
[Source: World Health Organization. Preventing and controlling Iron Deficiency Anaemia through primary health care. Available at: http://www.who.int/nutrition/publications/micronutrients/anaemia_iron_deficiency]
Thursday, 28 November 2013
Monday, 11 November 2013
Tuesday, 13 August 2013
Wednesday, 10 July 2013