This excerpt taken from the ELN 6-K filed Oct 27, 2005.
The comprehensive Tysabri safety evaluation for multiple sclerosis (MS), Crohns Disease (CD) and rheumatoid arthritis has been completed and the findings resulted in no new confirmed cases of progressive multifocal leukoencephalopathy (PML). The companies have previously reported three confirmed cases of PML, two of which were fatal. On September 26, 2005, Elan and Biogen Idec announced the submission of a supplemental Biologics License Application (sBLA) for Tysabri to the U.S. Food and Drug Administration (FDA) for the treatment of MS. The companies have requested Priority Review designation from the FDA. The sBLA includes final two-year data from the Phase III AFFIRM monotherapy trial and SENTINEL add-on trial with AVONEX® (Interferon beta-1a) in MS,
the integrated safety assessment of patients treated with TYSABRI in clinical trials, a revised label and a risk management plan. The companies have also submitted a similar data package to the European Medicines Agency. The process to restart clinical trials in MS is ongoing.
This excerpt taken from the ELN 6-K filed Jul 28, 2005.
As previously announced on February 28, 2005, Elan and Biogen Idec voluntarily suspended Tysabri from the U.S. market and all ongoing clinical trials. Elan and Biogen Idecs comprehensive safety evaluation concerning Tysabri is ongoing. The Tysabri expected key milestones for 2005 for MS, Crohns disease and rheumatoid arthritis will be reviewed once the results of the safety evaluation have been discussed with regulatory agencies to determine the appropriate risk benefit profile and the path forward for Tysabri.
On June 30, 2005, Elan and Biogen Idec announced that ENCORE, the second Phase III induction trial of Tysabri for the treatment of moderately to severely active Crohns disease in patients with evidence of active inflammation, met the primary endpoint of clinical response as defined by a 70 point decrease in baseline Crohns Disease Activity Index (CDAI) score at both weeks 8 and 12. In addition, ENCORE met all of its secondary endpoints including clinical remission at both weeks 8 and 12. Clinical remission was defined as achieving a CDAI score of equal to or less than 150 at both weeks 8 and 12. There were no notable differences in the overall rates of adverse events or serious adverse events between the TYSABRI and placebo treatment groups. The most common adverse events seen in the trial were headache, nausea, abdominal pain and nasopharyngitis.
The full data from ENCORE, including further sub-analysis of response and remission rates as well as clinical effect at other time points, effect on inflammatory markers and quality of life data will be presented at an upcoming medical meeting.