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Amgen Warns of More Aranesp Lable Changes
Dec 10, 2007 | Parker Waichman Alonso LLP
Aranesp, an anemia drug often used to treat chemotherapy patients, could soon have safety information on its label updated yet again, the drug’s maker announced last week. Amgen Inc. announced that it was considering label changes for Aranesp after the results of a study done on breast cancer patients treated with the drug showed that it offered them little help, and also placed them at a higher risk of death.
The Aranesp breast cancer study was one of 5 clinical trials that Amgen had agreed to after the safety of Aranesp was called into question. Aranesp, and two other drugs made by Amgen, Epogen and Procrit, are all part of a class of drugs known as erythropoiesis-stimulating agents (ESAs). Procrit is marketed by Johnson & Johnson under a licensing agreement with Amgen.
ESAs treat anemia in patients with kidney disease or certain cancers by boosting red blood cells. However, several studies have linked the anemia drugs to cardiovascular problems and deaths. They have also been tied to worsening tumors when used in cancer patients. A year ago, the Food & Drug Administration (FDA) ordered a “black box” warning regarding cardiovascular problems and other safety issues posed by the drugs be included on their labels. In March, the FDA added a black box warning to the drugs’ labels cautioning doctors that the medications should be administered at the lowest dose possible in order to bring red blood cell counts to the lowest level necessary to avoid transfusions. Last month, that black box warning was modified to include more specific dosing information.
Following the release of the Aranesp breast cancer study, the FDA announced that it would be holding yet another advisory panel meeting in March to discuss the safety of Aranesp, Apogent and Procrit. The March meeting will be the fourth time the FDA has held such a meeting to discuss ESAs. Following one of these meetings in May, the Centers for Medicare and Medicaid Services changed the reimbursement policy for Aranesp and other ESAs. Now doctors will only be paid for using a low dose of the drug.
None of this is good news for Amgen, as Aranesp is its biggest selling product. Amgen, based in Thousand Oaks, Calif., has lost about $19 billion in market value this year after studies showed its anemia drugs raised the risk of heart attack, stroke and death at high doses. Last week, after it announced that it was considering more label changes, Amgen stock dropped more than 5 percent. The worst possible outcome for Amgen would be if the latest breast cancer data convinced the FDA panel to vote to recommend against using ESAs to treat other cancers where there's been negative data as well, such as neck and head cancer.
