August 1, 2008
Amgen Told to Reword Drug Label
The New York Times reports that the FDA has ordered Amgen to change the labels for its anemia drugs, which could further restrict their use in treating patients with cancer. This is the first time the FDA has invoked authority under a 2007 law that empowered it to order changes in a drug's prescribing information. Andrew Pollack writes,
The move, which the F.D.A. announced on Wednesday, represents the first time the agency has invoked authority under a 2007 law that empowered it to order changes in a drug’s prescribing information. Previously, the F.D.A. could only negotiate with a drug’s manufacturer to change the label.
Sales of the drugs, Aranesp and Procrit, have already plummeted in the last year because of studies suggesting that their use to treat the anemia caused by chemotherapy could actually make cancer worse or shorten lives. Procrit is manufactured by Amgen but sold under license by Johnson & Johnson.
Sales of Aranesp, generally considered Amgen’s flagship product, fell 13 percent in the second quarter from a year earlier, to $825 million, the company announced Monday in posting its quarterly results. In the United States alone, sales plunged 26 percent, to $427 million.
Yaron Werber, a biotechnology analyst at Citi Investment Research, estimated that the new label could reduce the use of Aranesp for cancer patients in this country — the drug is also used by people with kidney disease — by an additional 40 percent, further cutting annual sales by about $264 million.
Despite the concerns about the drug, sales of Aranesp and Amgen’s overall financial results were better than Wall Street expected in the second quarter. That, plus the positive result of a clinical trial for a new bone drug, lifted Amgen shares this week. Shares of Amgen rose 2 cents, to $62.30 Wednesday, near their 52-week high.
Amgen said in a statement Wednesday that the new label was consistent with its expectations and that it had already factored the impact of the label change into updated financial guidance it provided to investors on Monday.
Johnson & Johnson said it would cooperate with the F.D.A. in using the new label. Its sales of Procrit and a similar drug, Eprex, dropped 14 percent worldwide in the second quarter, to $652 million, and fell 23 percent in the United States to $346 million. Because the company is larger and more diversified than Amgen, the sales of any one drug tend not to have as large an impact on its financial performance.
The new labels will say that treatment with the drugs should not begin until a patient’s hemoglobin drops to 10 grams per deciliter of blood. And language is being removed that seemed to imply that it was safe to continue treating patients until their hemoglobin rose to 12 grams per deciliter. Hemoglobin is the oxygen-carrying component of blood and is at low levels in people with anemia, causing problems like fatigue. There are no accepted theories yet on why high doses of the anemia drugs seem to make cancer worse.
The new labels also say the drugs should not be used if the chemotherapy is being given to cure patients, rather than to extend their lives. While that would be left to a doctor to judge, it would very likely apply, for instance, to so-called adjuvant therapy, in which chemotherapy is used after a tumor is removed by surgery in hopes of preventing cancer from coming back. When cancer is advanced, chemotherapy is often not considered curative.
However, the new labels will not advise against use of the drugs for all patients with breast cancer or head and neck cancer. An advisory panel to the F.D.A. in March had called for such an advisory, because the drugs’ risks seemed to be stronger for those two types of cancer.
One effect of the label changes could be to make it less likely that Medicare would loosen reimbursement policies for the drugs.
Amgen and many oncologists have been trying to get Medicare to amend a policy in which it will not pay for use of the drugs if hemoglobin is above 10. In their arguments, the company and doctors pointed to the drugs’ labels, which seemed to suggest that the F.D.A. thought that a hemoglobin level of up to 12 was safe.
But now the F.D.A. has also adopted the 10 gram level for initiating cancer therapy, and mention of 12 grams has been removed from the label.
Dr. Richard Pazdur, director of the F.D.A.’s oncology drug office, said that the mention of the level of 12 was confusing people, making them think hemoglobins up to 12 were safe when, in fact, the safety is unknown.
“We felt people interpreted this as an upper safety limit,” he said in an interview Wednesday. He said a hemoglobin level of 8 to 9, just high enough to avoid blood transfusions, was appropriate, though the new labels do not state a specific figure. The labels for the drugs have already been changed a few times since new safety concerns arose early last year. The F.D.A. and Amgen have been negotiating the latest changes since the advisory committee in March recommended further restrictions on use of the drugs.
While the company and the agency agreed on most language, there were some points on which they could not reach agreement, Dr. Pazdur said. That prompted the F.D.A. to invoke its new authority to order the changes, he said.
Amgen had wanted the label to give doctors discretion to initiate therapy before hemoglobin levels dropped to 10 in patients who could not tolerate that degree of anemia. And it wanted mention of the 12 gram upper limit for stopping therapy.
August 1, 2008 | Permalink
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