|
|
 | | | |
- close
- close
- close
- close
| |||||||||
This excerpt taken from the ELN 20-F filed Feb 28, 2007. Evaluating
Tysabri in Crohn’s Disease
In collaboration with Biogen Idec, we are evaluating Tysabri
as a treatment for CD. In September 2004, we submitted a
Marketing Authorization Application to the EMEA for the approval
of Tysabri for the treatment of CD. Following approval of
Tysabri as a treatment for MS in 2006, we have
re-initiated discussion with the EMEA and expect European
regulatory action regarding Tysabri in CD in 2007. A sBLA
for Tysabri as a treatment for CD in the
Table of Contents
United States was filed with the FDA on December 15, 2006
and has been accepted for review. The filing was based on the
results of three randomized, double-blind, placebo-controlled,
multi-center trials of Tysabri assessing its safety and
efficacy as both an induction and maintenance therapy.
This excerpt taken from the ELN 20-F filed Mar 30, 2006. Evaluating
Tysabri in Crohn’s Disease
In collaboration with Biogen Idec, we are evaluating Tysabri
as a treatment for CD. In September 2004, we submitted a
Marketing Authorization Application to the EMEA for the approval
of Tysabri for the treatment of CD. The application
included induction data and
12-month
data from a Phase 3 maintenance trial, ENACT-2, showing
sustained response, remission, and withdrawal from
corticosteroids in a significant number of patients. In 2006, we
expect European regulatory action regarding the potential
approval of Tysabri in CD, dependent upon completion of
Table of Contents
the regulatory review of Tysabri in MS. We expect to file
a Biologics License Application (BLA) for Tysabri as a
treatment for CD in the United States in 2006.
| EXCERPTS ON THIS PAGE:
|
| |||||||
