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FDA Approves TYSABRIŽ (natalizumab) for the Treatment of Moderate-to-Severe Crohn's Disease

DUBLIN, IRELAND and CAMBRIDGE, MA, USA --January 14, 2008 -- Elan Corporation, plc and Biogen Idec today announced the approval of a supplemental Biologics License Application (sBLA) by the U.S. Food and Drug Administration (FDA) for TYSABRIŽ (natalizumab). TYSABRI is now approved for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha. TYSABRI will be available for the treatment of CD upon the completion of key implementation activities related to the approved risk management plan. The companies anticipate TYSABRI will be available to Crohn's patients by the end of February 2008.

"The FDA's approval of TYSABRI is an important step forward in the treatment of Crohn's disease," said Dr. Stephen Hanauer, Professor of Medicine & Clinical Pharmacology & Chief of the Section of Gastroenterology at the University of Chicago Pritzker School of Medicine. "A significant number of patients either fail or cannot tolerate current therapies. The unique mechanism of action of TYSABRI affords us a new class of therapy in our fight against this debilitating disease."

The FDA granted approval based on its review of TYSABRI CD clinical trial data and overall safety data. The approval is accompanied by robust labeling with safety warnings; and a CD-specific risk management plan (including the mandatory TOUCH™ Prescribing Program) designed to inform prescribers, patients and infusion centers about the use of TYSABRI and to minimize potential risk of progressive multifocal leukoencephalopathy (PML) and other opportunistic infections.


SOURCE: Elan Corporation

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