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FDA: More Label Warnings for Anemia Drugs

The regulatory agency issues further label revisions for drugs like Amgen's Aranesp and J&J's Procrit.

The Food and Drug Administration on Wednesday issued anticipated label revisions for anemia drugs such as

Amgen's

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Aranesp and

Johnson & Johnson's

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Procrit.

Revisions have been expected since a

March advisory panel

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recommended to limit the drugs' use. The drugs, formally known as erythropoiesis stimulating agents, or ESAs, prompt the production of hemoglobin in patients undergoing cancer treatments, which can often cause severe anemia.

But data from clinical trials have shown that higher doses of the drugs may result in worse outcomes, such as higher risk of death and possibly tumor growth, for cancer patients.

Following a previous FDA advisory panel, in May of 2007, labels were changed to recommend the lowest dose of the drug also that patients hemoglobin levels not rise above 12 grams per deciliter.

The new revisions -- subsequent to the March 2008 advisory panel -- go a bit further. The new label mandate that patients with hemoglobin levels greater than or equal to 10 grams per deciliter not be started on the anemia drugs. Recall that Amgen had previously argued against Medicare's decision to not reimburse for use in patients with hemoglobin levels above 10.

Following the recommendation of the advisory committee, the new labels will also say the ESAs should not be used when chemotherapy is being used with the "intent to cure" the patient of cancer. Exactly how this will be interpreted is yet unknown, although it may refer to early-stage cancer patients who are being treated with adjuvant chemotherapy with the goal of complete elimination of the cancer.

The March panel also recommended that anemia drugs should not be used in patients with metastatic breast cancer or cancer of the head and neck. This is one place that the FDA apparently overruled, as that recommendation will not be in the label revisions.

The aforementioned safety concerns and reimbursement issues have depleted sales of these drugs -- which make up Amgen's most profitable franchise -- over the past year. In the recent quarter, Aranesp sales were down 13% year over year but surpassed expectations, contributing $835 million to Amgen's quarterly revenue. CEO Kevin Sharer said sales will likely enter 2009 at a yet lower rate in light of label changes.

"This label is consistent with our expectations," said Amgen in a statement on Wednesday in response to receipt of the FDA's revisions. "We will soon be communicating the revised product labeling for ESAs to both physicians and patients."

The company also said that the potential impact of this revised label was factored into its updated guidance -- on Monday Amgen raised its revenue guidance to between $14.6 billion and $14.9 billion, from a prior range of $14.2 billion to $14.6 billion. On a per-share basis, the company anticipates adjusted profit of between $4.25 and $4.45, up from a prior range of between $4 and $4.30.

Amgen's shares closed Wednesday essentially flat. J&J closed down 0.6%.