OCTOBER 18, 2010, 3:20 P.M. ET
FDA Panel Backs Use Of Amgen's Aranesp For Kidney Disease Patients
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--A Food and Drug Administration panel said Monday the agency should continue to allow the use of Amgen Inc.'s (AMGN) Aranesp and similar drugs in patients with chronic kidney disease who are not on dialysis.
The agency's cardiovascular and renal drugs advisory panel is currently meeting to discuss whether the use of Aranesp in patients with kidney disease should be restricted to certain patients--such as those who are undergoing kidney dialysis--or whether doses should be lowered.
The panel voted 15-to-1 with one person abstaining against a question that asked if the indication for Aranesp "for the treatment of anemia associated with chronic renal failure for patients not on dialysis be withdrawn." Patients who aren't on dialysis generally have less severe kidney disease than patients who are on dialysis, which acts to take the place of failing kidneys by filtering bodily fluids.
The panel, however, could vote later Monday to lower doses of the drug or to recommend other restrictions. The panel meeting was prompted by new concerns about whether Aranesp and similar drugs might increase risks of strokes and other cardiovascular problems after the results of a clinical study known as TREAT were released about a year ago.
That study, which looked at the use of Aranesp in patients with kidney disease who were not on dialysis, didn't meet a goal of reducing death and cardiovascular events in patients whose hemoglobin levels were targeted at 13 grams per deciliter of blood. [The current drug labels recommend not exceeding 12.] It also showed patients treated with Aranesp had double the rate of strokes compared with patients not receiving the drug.
A warning about the risk of stroke was added to Aranesp's label along with two other drugs, Epogen and Procrit, as a result of the TREAT study. The FDA is asking the panel whether additional steps are needed beyond the label change.
Aranesp, Epogen and Procrit fall into a class known as erythropoiesis-stimulating agents, or ESAs, and are designed to treat anemia by boosting the number of red blood cells. Amgen makes all three drugs, but Procrit is marketed by a unit of Johnson & Johnson (JNJ).
Anemia is a common side effect in patients with chronic kidney disease and patients undergoing chemotherapy. If anemia can't be controlled patients need to undergo blood transfusions. ESAs have been shown to reduce blood transfusion rates.
ESAs, however, have been associated with various safety problems including blood clots and concerns they promote tumor growth when used to target blood hemoglobin levels higher than what's recommended in the labels. The FDA has brought safety issues to various FDA panels, and warnings on the drugs' labels have been updated several times since 2007. Although safety problems have been seen when the drugs were used to target higher-than-recommended hemoglobin levels, it's not entirely clear what hemoglobin level should be targeted to avoid safety problems and provide benefits to patients.
Earlier this year, the FDA said it would place restrictions on ESAs with regard to use in cancer patients by setting up a program that will require doctors to register and undergo training on the risks and benefits of the drugs in order to continue prescribing the medications.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
http://online.wsj.com/article/BT-CO-20101018-711702.html
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