F.D.A. to Tighten Use of Amgen Anemia Drugs
By ANDREW POLLACK
The Food and Drug Administration is ordering Amgen to change the labels for its big-selling anemia drugs in a way that could further restrict their use in treating patients with cancer.
The move, which the F.D.A. is expected to announce 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 the drug’s manufacturer to change the label.
Sales of the drugs, Aranesp and Procrit, have already plummeted in recent months 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 late Monday in posting its quarterly results. In the United States alone, sales plunged 26 percent, to $427 million.
Still, sales of Aranesp and Amgen’s overall financial results were better than Wall Street expected. That, plus the positive result of a clinical trial for a new bone drug have bolstered Amgen shares this week. The stock was at $61.90 in mid-afternoon trading, near its 52-week high.
But the new labels might change that.
The new labels will say that treatment with the drugs should not begin until a patient’s hemoglobin drops to 10 grams a 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 a deciliter.
Hemoglobin is the oxygen-carrying component of blood and is at low levels in people with anemia, causing problems like fatigue.
The new labels also say the drugs should not be used if the intent of the chemotherapy is to cure a patient. While that would be left to a physician 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.
However, the new labels will not advise against use of the drugs for all patients with breast cancer or head and neck cancer, something that had been recommended by an advisory panel to the F.D.A. in March.
One impact of the label changes could be to make it less likely that Medicare will 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 use up to hemoglobin levels of 12 was safe.
But now the F.D.A. has also adopted the 10-gram level for initiating therapy, and any 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 believe hemoglobins up to 12 were safe when, in fact, the safety level 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 labels do not state a specific figure.
The labels for the drugs have already been changed more than once since safety concerns first arose early last year. The F.D.A. and Amgen have been negotiating the new 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 physicians 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.
Amgen had also wanted the label to allow treatment with the drugs for patients aiming for a cure if those patients were not eligible for blood transfusions.
Dr. Pazdur said there was not enough evidence to support the wording sought by Amgen.
The Food and Drug Administration is ordering Amgen to change the labels for its big-selling anemia drugs in a way that could further restrict their use in treating patients with cancer.
The move, which the F.D.A. is expected to announce 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 the drug’s manufacturer to change the label.
Sales of the drugs, Aranesp and Procrit, have already plummeted in recent months 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 late Monday in posting its quarterly results. In the United States alone, sales plunged 26 percent, to $427 million.
Still, sales of Aranesp and Amgen’s overall financial results were better than Wall Street expected. That, plus the positive result of a clinical trial for a new bone drug have bolstered Amgen shares this week. The stock was at $61.90 in mid-afternoon trading, near its 52-week high.
But the new labels might change that.
The new labels will say that treatment with the drugs should not begin until a patient’s hemoglobin drops to 10 grams a 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 a deciliter.
Hemoglobin is the oxygen-carrying component of blood and is at low levels in people with anemia, causing problems like fatigue.
The new labels also say the drugs should not be used if the intent of the chemotherapy is to cure a patient. While that would be left to a physician 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.
However, the new labels will not advise against use of the drugs for all patients with breast cancer or head and neck cancer, something that had been recommended by an advisory panel to the F.D.A. in March.
One impact of the label changes could be to make it less likely that Medicare will 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 use up to hemoglobin levels of 12 was safe.
But now the F.D.A. has also adopted the 10-gram level for initiating therapy, and any 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 believe hemoglobins up to 12 were safe when, in fact, the safety level 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 labels do not state a specific figure.
The labels for the drugs have already been changed more than once since safety concerns first arose early last year. The F.D.A. and Amgen have been negotiating the new 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 physicians 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.
Amgen had also wanted the label to allow treatment with the drugs for patients aiming for a cure if those patients were not eligible for blood transfusions.
Dr. Pazdur said there was not enough evidence to support the wording sought by Amgen.
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