TYSABRI® (natalizumab) Information Center

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To the MS Community:

Biogen Idec and Elan launched TYSABRI® (natalizumab) in some countries in Europe and reintroduced the product in the U.S. This represents an important step forward for people living with multiple sclerosis (MS), and we believe TYSABRI offers new hope in the management of this debilitating disease.

We are implementing risk management plans in the U.S. and Europe to facilitate appropriate use of TYSABRI, to inform benefit-risk discussions between physicians and patients and to assess the incidence and rate of progressive multifocal leukoencephalopathy (PML) and serious opportunistic infections. As Biogen Idec, Elan and the FDA have stated previously, we anticipate there will be additional cases of PML with the use of TYSABRI. In addition, we expect that for the foreseeable future there will be many rumors and speculation regarding TYSABRI and suspected cases of PML. We expect to communicate critical information about TYSABRI to the MS community and other stakeholders at the appropriate time and manner.

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2006 TYSABRI® News Archive

Elan and Biogen Idec Submit Supplemental Biologics License Application to the FDA for the approval of TYSABRI® as a Treatment for Crohn’s Disease (12/15/2006)

TYSABRI® Maintained Remission in Patients with Moderate-to-Severe Crohn’s Disease Treated for Longer Than Two Years According to Data Presented This Week (10/24/06)

New Pharmacoeconomic Data on TYSABRI® Demonstrate Significant Reduction in Steroid Use and Hospitalizations in Patients with Multiple Sclerosis (10/6/06)

New Data Presented at ECTRIMS Congress Show TYSABRI® has Sustained Effect on Relapse Rate in Multiple Sclerosis Patients Treated for up to Three Years (9/29/06)

New Data on TYSABRI® Presented at ECTRIMS Congress Demonstrate Significant Improvement in Cognitive Function in Patients with Multiple Sclerosis (9/28/06)

Biogen Idec and Elan Announce Availability 0f TYSABRI® for the Treatment of Relapsing Forms of Multiple Sclerosis (7/24/06)

TYSABRI® Receives Approval in European Union for the Treatment of Relapsing Remitting Forms of Multiple Sclerosis (6/29/06)

FDA Approves the Reintroduction of TYSABRI® for the Treatment of Relapsing Forms of Multiple Sclerosis (6/5/06)

CHMP Issues Positive Opinion for TYSABRI® as a Treatment for Relapsing-Remitting Multiple Sclerosis (4/27/06)

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 (3/29/06)

Biogen Idec and Elan Announce that FDA Will Extend Regulatory Review Period for the Reintroduction of TYSABRI® for Multiple Sclerosis (3/22/06)

FDA Advisory Committee Unanimously Recommends Reintroduction of TYSABRI® for the Treatment of Relapsing Forms of Multiple Sclerosis (3/8/06)

TYSABRI® Two-Year Phase III Multiple Sclerosis Clinical Trial Results and Safety Evaluation Published in New England Journal of Medicine (3/1/06)

TYSABRI® Multiple Sclerosis Clinical Trial Hold Lifted by FDA; Biogen Idec and Elan to Resume Clinical Trial Dosing in MS (2/15/06)

Biogen Idec and Elan Announce Notification of FDA Advisory Committee Meeting to Review TYSABRI® for the Treatment of Multiple Sclerosis (1/23/06)

 

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