Can you hear the joyous singing from Amgen and Johnson & Johnson's headquarters? Yesterday, an FDA advisory panel decided not to strictly limit doses of the anemia drugs Aranesp, Epogen (Amgen) and Procrit (J&J)--though they did argue over what dosing levels are appropriate.
The drugs all have "black box" warnings that point out increased risks of heart problems when taken at high doses. Based on input from this meeting, FDA staff will revise the labeling again, perhaps tweaking the dosing, most probably removing claims that the drugs improve quality of life for patients, because the agency finds that data suspect.
Medicare types will be watching. Already, the agency that oversees Medicare said it wouldn't pay for the drugs except in certain circumstances and at certain doses--and those guidelines could change again, for better or worse. Meanwhile, Amgen's stock is rising on the news, and UBS upgraded it to "neutral" from sell.
- see the release from Amgen
- here's the report from the Los Angeles Times
- read an FDA official's musings on anemia drugs from the Wall Street Journal (sub. req.)
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