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Home Industry News Takeda applies for EU approval of Feraheme

Takeda applies for EU approval of Feraheme

1st July 2010

Takeda’s new Feraheme iron deficiency anaemia (IDA) treatment has had its marketing authorisation application accepted by the European Medicines Agency (EMEA).

The regulatory body has chosen to validate the therapy for review among patients with chronic kidney disease, following the submission of the application by Takeda’s collaborative partner AMAG Pharmaceuticals at the beginning of June 2010.

Feraheme has already been approved by the US Food and Drug Administration for this indication, while Takeda and AMAG are hoping to expand the specification of the therapy to apply to all IDA patients, regardless of underlying cause.

Dr Erich Brunn, chief executive officer of Takeda Pharmaceuticals Europe, said this is an “important first step forward” into a new therapeutic area.

He added: “Feraheme has the potential to provide physicians in Europe with an important new approach in the treatment of patients with iron deficiency anaemia.”

Last month, Takeda announced plans to begin a phase III clinical trial for Hematide, a therapy for anaemia in chronic renal failure patients.

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