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.