Luitpold Pharmaceuticals, Inc, a Daiichi Sankyo company, said the US Food and Drug Administration (FDA) has issued a non-approvable letter for its new drug application (NDA) for Injectafer (ferric carboxymaltose injection) (Internal name VIT-45), an intravenous iron injection, for the treatment of iron deficiency anaemia in women due to postpartum (PP) or heavy uterine bleeding (HUB).

In the non-approvable letter, the FDA requested safety data from additional clinical studies to address concerns over the safety of Injectafer in this population, specifically the mortality signal discussed at the February 1, 2008 meeting of the Drug Safety and Risk Management Advisory Committee.

"While we are disappointed about this latest decision, we are committed to the further development of Injectafer and are working on new studies in support of our application and to address the FDA's concerns," said Mary Jane Helenek, president and CEO.

In February 2008, the Drug Safety and Risk Management Advisory Committee of the FDA voted that that the available safety and efficacy data supported a favourable risk /benefit profile of Injectafer (ferric carboxymaltose injection) for the treatment of iron deficiency anaemia patients in women with heavy uterine or post-partum bleeding, but recommended that the usage be restricted to patients who have had an unsatisfactory response to oral iron or are intolerant to oral iron.

The development program for Injectafaer represents the largest prospectively enrolled programme of any intravenous iron product ever submitted to the Agency for approval.

Data were derived from 12 multicentre trials involving more than 3,000 subjects with iron deficiency anaemia secondary to a variety of conditions besides HUB and PP, including non-dialysis and haemodialysis dependent chronic kidney disease patients and patients with inflammatory bowel disease.

Iron deficiency anaemia represents a significant health issue in women. More than half of the 4 million women 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 will suffer from heavy uterine bleeding, defined as excessive or prolonged blood loss. Once approved, Injectafer will be marketed in the US by American Regent, Inc., a subsidiary of Luitpold Pharmaceuticals. Injectafer was approved in 18 countries in Europe in June 2007 and in Switzerland in November 2007.