Japan’s Daiichi Sankyo and Galenica of Switzerland have received some bad news from US regulators about their new injectable anaemia drug.

The US Food and Drug Administration has issued a non-approvable letter for the new intravenous iron replacement therapy, Injectafer/Ferinject (ferric carboxymaltose), for the treatment of iron deficiency anaemia in postpartum women and women with heavy uterine bleeding. The agency cited concerns with the benefit/risk ratio in the intended patient population, and the proposed dosing regimen and requested additional safety data from clinical studies.

The news comes as something of a surprise given that an FDA advisory panel had recommended approval of Injectafer, in February. The decision was announced by Luitpold Pharmaceuticals, a wholly owned US subsidiary of Daiichi Sankyo, which licensed Injectafer from Vifor Pharma (a subsidiary of Galenica). The treatment was approved in 18 countries in Europe in June 2007 and in Switzerland five months later.

Luitpold chief executive Mary Jane Helenek said that “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”.

The development programme for Injectafer represents the largest of any intravenous iron product ever submitted to the FDA for approval, Luitpold said. Data were derived from 12 multicentre trials involving more than 3,000 subjects with iron deficiency anaemia secondary to a variety of conditions, including non-dialysis and haemodialysis dependent chronic kidney disease patients and inflammatory bowel disease sufferers.