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This excerpt taken from the ELN 20-F filed Mar 30, 2006. Voluntary
Suspension of Tysabri
In late February 2005, Elan and Biogen Idec suspended the
marketing and dosing in clinical trials of Tysabri, based
on two reports of PML, one of which was fatal, in patients
treated for more than two years with Tysabri in
combination with Avonex in clinical trials. PML is a rare and
potentially fatal demyelinating disease of the central nervous
system.
We and Biogen Idec initiated a comprehensive safety evaluation
of Tysabri and any possible link to PML. The safety
evaluation was comprised of the review of all clinical trial
data. We and Biogen Idec worked with clinical trial
investigators and PML and neurology experts to evaluate more
than 3,000 patients in MS, CD and RA trials. The safety
evaluation also included a review of any reports of potential
PML in patients receiving Tysabri in the commercial
setting.
In March 2005, we and Biogen Idec announced that the safety
evaluation had led to a posthumous reassessment of PML in a
patient in an open label CD clinical trial. The patient died in
December 2003, and the case had originally been reported by a
clinical trial investigator as malignant astrocytoma. This
diagnosis was confirmed at the time by histopathology. The
patient had received eight doses of Tysabri over an
18-month
period, and prior medication history included multiple courses
of immunosuppressant agents.
In August 2005, we and Biogen Idec reported that findings from
the safety evaluation of Tysabri in patients with MS
resulted in no new confirmed cases of PML beyond the three
previously reported. On October 17, 2005, which marked the
completion of the safety review, we reported the same results
from our evaluation of patients with CD and RA.
More than 2,000 MS patients from clinical trials were eligible
for the safety evaluation, and more than 91 percent of
these patients agreed to participate. More than 1,500 CD and RA
patients from clinical trials were eligible for the safety
evaluation, and approximately 88 percent of these patients
participated.
In September 2005, Elan and Biogen Idec announced that the
companies had submitted an sBLA for Tysabri to the FDA
for the treatment of MS and would submit a similar data package
to the EMEA. In November 2005, the sBLA was accepted and
designated for Priority Review by the FDA, and the European
submission was accepted for review.
The sBLA included two-year data from the Phase 3 AFFIRM
monotherapy trial and SENTINEL add-on trial with Avonex in MS, a
revised label and risk management plan, and an integrated safety
assessment of Tysabri clinical trial patients.
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