Anemia drugs just can't get a break [1]. Now, the FDA is questioning whether the drugs--Amgen's Epogen and Aranesp and J&J's Procrit--actually improve kidney patients' quality of life.
In documents posted in advance of tomorrow's FDA advisory committee meeting, the agency said the data contained "important deficiencies." The committee is scheduled to discuss proper dosing of the drugs, which may increase cardiovascular and cancer risks at high doses [2]. After questions arose about these risks, Medicare changed its reimbursement for the drugs to limit dosing--and it's watching the FDA now to see whether further changes are needed.
- read the Wall Street Journal report [3]Â (sub. req.)
ALSO: Amgen's decision to cut its workforce maybe spark biotech start-ups. Report [4]
Related Articles:
New rules limit use of anemia drugs. Report [5]
New Medicare cap on anemia drugs could hammer Amgen. Report [6]
FDA panel votes for restrictions on anemia drugs. Report [7]
Amgen stock slips as anemia drug concerns rise. Report [1]
Major challenges loom for Amgen. Report [8]
Links:
[1] http://www.fiercebiotech.com/story/amgen-stock-slips-as-anemia-drug-concerns-rise/2007-03-02
[2] http://www.fiercebiotech.com/story/new-study-points-to-danger-of-anemia-drug/2006-11-16
[3] http://online.wsj.com/article/SB118917540863620676.html
[4] http://www.fiercebiotech.com/story/amgen-layoffs-good-news-ventura-county/2007-09-10
[5] http://www.fiercebiotech.com/story/new-rules-limit-use-of-anemia-drugs/2007-07-31
[6] http://www.fiercebiotech.com/story/new-medicare-cap-on-anemia-drugs-could-hammer-amgen/2007-05-15
[7] http://www.fiercebiotech.com/story/fda-panel-votes-for-restrictions-on-anemia-drugs/2007-05-11
[8] http://www.fiercebiotech.com/story/major-challenges-loom-for-amgen/2006-10-26