FDA staffers say that there is not enough data to ensure that two blockbuster anemia drugs--Amgen's Aranesp [1] and J&J's Procrit--are safe when taken by patients receiving chemotherapy. And the regulators may ask the companies to conduct new trials to put their drugs to the test. An FDA panel is being tasked to review anemia drugs on Thursday. The agency recently required new safety labels warning patients and physicians about using dosages of the drugs at levels that are higher than recommended.
- read the AP report [2] on the FDA's review
Related Articles:
Regulators question anemia drugs. Report [3]
New study points to danger of anemia drug. Report [4]
Amgen stock slips as anemia drug concerns rise. Report [5]
Links:
[1] http://www.fiercebiotech.com/story/amgen-breathes-a-sigh-of-relief-on-aranesp-results/2007-04-19
[2] http://www.forbes.com/feeds/ap/2007/05/08/ap3697286.html
[3] http://www.fiercebiotech.com/story/spotlight-regulators-question-anemia-drugs/2007-04-30
[4] http://www.fiercebiotech.com/story/new-study-points-to-danger-of-anemia-drug/2006-11-16
[5] http://www.fiercebiotech.com/story/amgen-stock-slips-as-anemia-drug-concerns-rise/2007-03-02