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Home Industry News Amgen in talks with FDA over ESA label update

Amgen in talks with FDA over ESA label update

7th December 2007

Amgen has confirmed that it is in discussions with the US Food and Drug Administration (FDA) over a possible update to the safety information on the labelling for all its erythropoiesis-stimulating agents (ESAs).

The decision to consult the regulatory body follows the release of new safety data from its Prepare interim study in neoadjuvant breast cancer and the recently published follow up data from the Gynaecologic Oncology Group (GOG) study in cervical cancer.

Amgen has stated that its interactions with the FDA over updated labelling have not been finalised but the company was committed to providing appropriate communications to patients and healthcare professionals.

Both parties are discussing the label changes using the regulatory mechanism known as a ‘changes being effected’ process.

Roger M Perlmutter, executive vice-president of research and development at Amgen, explained: “The Prepare and GOG studies were off-label, high-haemoglobin target studies that contain important information relevant to specific patient populations receiving ESAs.”

As additional study results and new information becomes available, Amgen will communicate the data and work with the FDA to update its product labels, he said.

Earlier this year, Amgen announced that Aranesp (darbepoetin alfa) had been approved by the European commission for use in paediatric patients suffering from chronic renal failure, irrespective of whether or not they are on dialysis.

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