Galenica Holding's anaemia drug Injectafer gets US FDA approval

The US Food and Drug Administration's (FDA) advisory committee has issued a positive recommendation for Galenica Holding's iron replacement therapy Ferinject/Injectafer.

According to Galenica, the committee has voted for Injectafer (Ferinject, ferric carboxymaltose injection), for the treatment of iron deficiency anaemia in women due to heavy uterine and postpartum bleeding. At the close of the meeting, the Advisory Committee voted that the available safety and efficacy data support a favourable risk/benefit profile of Injectafer for the treatment of the mentioned patient groups in case of an unsatisfactory response to oral iron or an intolerance to oral iron.

The FDA is expected to make a decision on the New Drug Application (NDA) requesting approval for the use of Injectafer in these patient populations by mid-March, 2008. The agency is not bound by the Committee's recommendation but takes its advice into consideration when reviewing products for approval.

The development programme for Injectafer represents the largest prospectively enrolled program of any intravenous iron product ever submitted to the Agency for approval. Data were derived from 12 studies involving more than 2,000 patients.

Iron deficiency anaemia represents a significant health issue in women. More than half of the 4 million women in the United States who give birth each year develop iron deficiency and approximately 1 million of these women progress to iron deficiency anaemia. In addition, as many as one in five women suffers from heavy uterine bleeding, defined as excessive or prolonged blood loss.

The innovative injectable iron replacement product Ferinject was registered by the public health authorities in 18 EU countries in September 2007 and in Switzerland in November 2007. It has been used to treat iron deficiency diseases in Germany since November 2007 and will be on sale in Switzerland from mid-February 2008.

Galenica and Luitpold Pharmaceuticals, Inc. said recommendation establishes a path forward with the FDA. Galenica and Luitpold are committed to working closely with the FDA to see the product through approval. The mentioned second line treatment recommendation, when oral iron is ineffective, is clearly in-line with the current labelling in Europe and in Switzerland: all countries have included a similar restriction, particularly due to the fact that all intravenous iron products are in the same situation, the company said.