Proposed Aranesp, Epogen, Procrit Dosage Limit Rejected by FDA Advisory PanelSep 12, 2007 | Parker Waichman LLP, LLP
An advisory panel has concluded that Amgen's anemia medications should not be subject to a new dosage limit proposed by the Food & Drug Administration (FDA). Yesterday, the panel voted 15-4 against a new limit for Aranesp, Epogen and Procrit, which are used to treat anemia in patients experiencing kidney failure. All three are manufactured by Amgen, although Procrit is sold by Johnson & Johnson under a licensing agreement.
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. The drugs improve anemia by increasing red blood cells, something that had previously been accomplished with blood transfusions. But soon after Epogen was introduced, some doctors attempted to use it to increase patients’ hemoglobin (the part of the blood cell that carries oxygen) to levels as high as 14 grams. A healthy person would normally have a hemoglobin level between 13.5 and 14. Two clinical trials showed that the large dosage required to attain such high hemoglobin levels could lead to heart problems and death. 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. The warning labels said hemoglobin levels should not be allowed to go above 12 grams per deciliter of blood.
Shortly after the FDA added the black box warning, Medicare announced that program would not pay for Aranesp, Epogen and Procrit in patients whose hemoglobin levels were at 10 grams per deciliter. That decision sparked controversy among doctors and members of Congress. As a result, Medicare had been waiting for the outcome of yesterday’s advisory panel meeting before enforcing its new dosing regulations.
Prior to the meeting, the FDA had proposed setting a target hemoglobin level of 11 for the medications. The panel heard from representatives from Amgen, as well as patient representatives and kidney specialists. They expressed fears that the proposed limit would leave many patients under-treated, and at risk for blood transfusions. Many panelists who voted against the proposed level of 11 said that more flexibility in dosing was needed, although most agreed that some guidelines were necessary. Several backed Amgen’s proposed hemoglobin range of 10- to-12 grams. While higher than the FDA proposed limit, that range is still lower than the 11-to-13 range found in some kidney treatment guidelines. At least one panel member expressed concern that 18 years after Epogen received its approval, dosage was still as subject of controversy. He criticized Amgen for not conducting more clinical trails.
Despite the vote in Amgen’s favor, Aranesp, Epogen and Procrit could still face additional changes to their labels. The FDA says that claims made on the labels that the drugs improve patient’s quality of life did not stand up to clinical scrutiny. The FDA is considering removing those statements from the products’ labels; however the advisory panel was not asked to vote on that issue.