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FDA approves anaemia drug Mircera


Pharmaceutical giant Roche has received approval from the Food and Drug Administration (FDA) for its anaemia drug Mircera (methoxy polyethylene glycol-epoetin beta).

But the Swiss company is still awaiting the outcome of a patent case before launching the drug in the United States.

Mircera has been approved for patients with anaemia caused by kidney failure, and the firm claims it is the only medication capable of stabilising patients’ haemoglobin levels in a single dose.

But a US District Court jury in Boston ruled last month that Roche’s drug infringes 11 patents used in rival Amgen’s Aranesp (darbepoetin alfa), and Epogen (epoetin alfa) medicines.

Those two drugs had combined combined sales of more than $6bn last year, and the legal battle looks set to continue for some time.

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Roche is considering appealing against the court decision, but Amgen has already moved to prohibit the company from launching the drug, and is seeking an official injunction to stop the sale of Mircera in the US.

Mircera is already on sale in Britain, Austria, Sweden, Germany, and Norway.

William Burns, chief executive of Roche’s pharmaceutical division, said the FDA approval is “another significant milestone” for the firm.

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