"On February 28, 2005, Elan and Biogen Idec voluntarily suspended TYSABRI from the U.S. market and dosing in all ongoing clinical trials based on reports of PML. Elan and Biogen Idec completed a comprehensive safety evaluation of more than 3,000 TYSABRI patients in collaboration with leading experts in PML and MS. The results of the safety evaluation yielded no new confirmed cases of PML beyond the three previously reported.
On March 8, 2006, the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously to recommend reintroduction of TYSABRI as a treatment for relapsing forms of MS. The companies anticipate action by the Agency regarding the reintroduction for TYSABRI in the U.S. on or before June 28, 2006. The companies' application for approval of TYSABRI as a treatment for MS is also under review with the European Medicines Agency.
On March 29, 2006, the companies announced they have enrolled and dosed the first patients in the TYSABRI monotherapy safety extension study program in MS. Patients who previously participated in the Phase III MS trials and subsequent safety evaluation are eligible to be screened for entry in this open label multi-center study. Sites throughout Europe, the United States, Canada, Australia, New Zealand and Israel are expected to enroll patients....."
Recent News
» CHMP Issues Positive Opinion for TYSABRI® as a Treatment for Relapsing-Remitting Multiple Sclerosis (4/28/06)
» New Data on TYSABRI® Demonstrate Significant Effects on Health-Related Quality of Life Measures in Patients with Multiple Sclerosis (4/6/06)
» Biogen Idec and Elan Announce Re-Initiation of TYSABRI® Clinical Trial Dosing in Multiple Sclerosis (29/3/2006)
» Biogen Idec and Elan Announce That FDA Will Extend Regulatory Review Period for the Reintroduction of TYSABRI® for Multiple Sclerosis(3/22/2006)
» FDA Advisory Committee Unanimously Recommends Reintroduction of TYSABRI® for the Treatment of Relapsing Forms of Multiple Sclerosis(3/8/2006)
» TYSABRI® Two-Year Phase III Multiple Sclerosis Clinical Trial Results and Safety Evaluation Published in New England Journal of Medicine; TYSABRI Currently Under Review with U.S. and European Regulatory Authorities(3/1/2006)
» Elan Announces the Suspension of Trading of Its Shares Commencing March 7, 2006 For Up to Two Days; Suspension of Trading Due to Two Day FDA Advisory Committee Meeting to Review Tysabri(2/28/2006)
» TYSABRI® Multiple Sclerosis Clinical Trial Hold Lifted by FDA; Biogen Idec and Elan to Resume Clinical Trial Dosing in MS(2/15/2006)
» Biogen Idec and Elan Announce Notification of FDA Advisory Committee Meeting to Review TYSABRI® for the Treatment of Multiple Sclerosis (1/23/06)
» Biogen Idec and Elan Announce FDA Acceptance of Supplemental Biologics License Application and Priority Review Designation for TYSABRI® in Multiple Sclerosis(11/17/05)
» Elan and Biogen Idec Announce TYSABRI® Safety Evaluation Findings in Crohn's Disease and Rheumatoid /Arthritis Patients; TYSABRI Safety Evaluation Complete; No New Confirmed Cases of PML (10/17/05)
» Biogen Idec and Elan Submit Supplemental Biologics License Application to the FDA for TYSABRI® in Multiple Sclerosis(9/26/05)
» Elan and Biogen Idec Provide an Update on TYSABRI® (9/20/05)
» Biogen Idec and Elan Announce TYSABRI® Safety Evaluation Update (8/9/05)
» Two-Year SENTINEL Data Evaluating TYSABRI® in Addition to AVONEX® Reinforce Efficacy in Multiple Sclerosis (7/18/05)
» TYSABRI® Phase III Induction Trial in Crohn's Disease Meets Primary Endpoint; TYSABRI Induced Statistically Significant Response and Remission in Patients with Active Disease (6/30/05)
» Positive One-Year Data From SENTINEL Trial Evaluating Addition of TYSABRI® to AVONEX® Presented at American Academy of Neurology Meeting;Data from GLANCE Safety Study Also Presented (4/13/05)
» TYSABRI® Two-Year Monotherapy Data Support Positive One-Year Efficacy Findings and Show Significant Reduction in Risk of Disability Progression (4/12/05)
» Elan and Biogen Idec Announce TYSABRI® Update (3/30/05)
» Biogen Idec and Elan Announce Update on TYSABRI® 3/3/05
» Biogen Idec and Elan Announce Voluntary Suspension of TYSABRI®
