This excerpt taken from the ELN 6-K filed Jan 14, 2008.
DUBLIN, Ireland and CAMBRIDGE, Mass. – January 14, 2008 - Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) today announced the approval of a supplemental Biologics License Application (sBLA) by the U.S. Food and Drug Administration (FDA) for TYSABRI® (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.
“We are delighted that TYSABRI will be available for Crohn’s patients and their physicians, who continue to need new therapeutic options with novel mechanisms of action,” said Gordon Francis, MD, Senior Vice President, Global Clinical Development, Elan. “We are committed to providing therapeutic choice to those patients who can benefit from TYSABRI, and will continue to work with the FDA and the medical community to implement the TOUCH™ Prescribing Program for Crohn’s patients.”
“We are pleased with the FDA’s decision to make TYSABRI available to Crohn’s patients suffering from this chronic, debilitating disease," said Evan Beckman, MD, Senior Vice President, Immunology Research and Development, Biogen Idec. “Despite the therapeutic advances of the TNF-alpha inhibitors in CD, there remains a significant unmet need for Crohn’s patients who have inadequate responses to, or are unable to tolerate, current CD therapies.”