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 | News: Tysabri Approved For Return in Europe |
 Following the lead of the United States Food and Drug Administration, the European Commission announced its re-approval of Tysabri as a single therapy for highly active relapsing-remitting multiple sclerosis. More specifically, it is indicated for patients unresponsive to the CRABs, or for patients with very severe, rapid forms of the disease.
"Today marks an important step forward for the European MS patient community," said James C. Mullen, Chief Executive Officer, Biogen Idec. "TYSABRI represents one of the most significant advances in MS treatment in nearly 10 years and provides patients living with this disabling disease an important new therapeutic choice."
"This decision means that patients in Europe who are suffering from this chronic, debilitating disease now have an effective new treatment alternative," said Kelly Martin, President and Chief Executive Officer, Elan.
Click "read more" for the full press release...
Press Release
Source: Biogen Idec and Elan Corporation, plc
TYSABRI(R) Receives Approval in European Union for the Treatment of Relapsing Remitting Forms of Multiple Sclerosis
Thursday June 29, 2:30 am ET
ZUG, Switzerland & DUBLIN, Ireland--(BUSINESS WIRE)--June 29, 2006--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) today announced that they received approval from the European Commission to market TYSABRIŽ (natalizumab) as a treatment for relapsing remitting multiple sclerosis (MS) to delay the progression of disability and reduce the frequency of relapses. TYSABRI is indicated as a single disease modifying therapy in highly active relapsing remitting MS for patients with high disease activity despite treatment with a beta-interferon or in patients with rapidly evolving severe relapsing remitting MS.
The approval was based on a submission that included TYSABRI two-year Phase III clinical trial data, findings from the comprehensive safety evaluation, suggested labeling, and a risk management plan designed to inform physicians and patients of the benefits and risks of TYSABRI treatment and minimize the potential risk of progressive multifocal leukoencephalopathy (PML) and other opportunistic infections.
"Today marks an important step forward for the European MS patient community," said James C. Mullen, Chief Executive Officer, Biogen Idec. "TYSABRI represents one of the most significant advances in MS treatment in nearly 10 years and provides patients living with this disabling disease an important new therapeutic choice."
"This decision means that patients in Europe who are suffering from this chronic, debilitating disease now have an effective new treatment alternative," said Kelly Martin, President and Chief Executive Officer, Elan.
This action follows a recommendation made by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), which on April 28, 2006, issued a positive opinion recommending marketing authorization for TYSABRI.
For more information about TYSABRI please visit www.biogenidec.com or www.elan.com.
About Biogen Idec
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
About Elan
Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.
Contact:
Media Contacts:
Biogen Idec
Katja Buller, +41 41 392 1792
or
Amy Brockelman, +1 617-914-6524
or
Elan
Davia B. Temin, +1 212-407-5740
or
Elizabeth Headon, +353 1 498 0300
or
Investor Contacts:
Biogen Idec
Elizabeth Woo, +1 617-679-2812
or
Elan
Emer Reynolds, +353 1 709 4000
or
Chris Burns, 800-252-3526
Source: Biogen Idec and Elan Corporation, plc
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