Injectafer Receives US FDA Approval for Iron Deficiency Anaemia Treatment

26 July 2013 --- 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.