Elan and Biogen Idec have won the backing of an FDA expert committee in its quest to gain regulatory approval for Tysabri as a therapy for Crohn's disease. The backing came for the use of Tysabri for Crohn's patients that either haven't benefited from existing therapies or can't tolerate them. The vote marks another careful step forward [1] for Tysabri, which has been linked to a deadly nervous system disease [2].
- check out the release [3] on the approval
- here's the AFX report [4] on the vote
Related Articles:
After reintroduction, Tysabri builds patient base [1]
FDA allows Tysabri back on market [5]
Links:
[1] http://www.fiercebiotech.com/story/after-reintroduction-tysabri-builds-patient-base/2007-07-23
[2] http://www.fiercebiotech.com/story/elan-hammered-on-reported-case-of-pml/2005-06-02
[3] http://www.fiercebiotech.com/press-releases/press-release-joint-fda-advisory-committee-recommends-approval-tysabri-crohns-disease
[4] http://www.forbes.com/business/feeds/afx/2007/08/01/afx3974633.html
[5] http://www.fiercebiotech.com/story/fda-allows-tysabri-back-on-market/2006-06-06