April 2008
To the MS Community:
It has been more than 20 months since Biogen Idec and Elan reintroduced TYSABRI® (natalizumab) in the U.S. and began launching in countries throughout the European Union, and we are pleased to see this therapy making an important impact on the lives of patients across the globe.
We responsibly reintroduced TYSABRI in the U.S. under one of the most comprehensive risk management plans in the industry - the TOUCH Prescribing Program - which is designed to facilitate the appropriate use of TYSABRI. Today, TYSABRI is approved in more than 30 countries, and most importantly, offers new hope to patients living with a serious, debilitating disease. Many patients have chosen to start TYSABRI therapy - as of the end of March 2008, approximately 26,000 patients were on commercial and clinical therapy worldwide. Specifically:
- In the U.S., approximately 15,300 patients were on TYSABRI therapy commercially and approximately 2,750 physicians have prescribed the therapy;
- Outside of the U.S., more than 10,200 patients were on TYSABRI therapy commercially;
- In global clinical trials, more than 600 patients were on TYSABRI therapy; and
- There have been no cases of progressive multifocal leukoencephalopathy (PML) since re-launch in the U.S. and launch internationally in July 2006.
We continue to hear remarkable stories of how TYSABRI has benefited patients and their families. There remains a significant unmet medical need in MS, and we believe TYSABRI can help address this need. We understand there is a lot of interest in TYSABRI, and we expect to continue to communicate important information to the MS community, including providing periodic safety updates at medical meetings. For more information on TYSABRI please visit www.tysabri.com or call
1-800-456-2255.
TYSABRI is a compelling therapy for the treatment of MS and we are pleased to make it available to patients. We remain committed as ever to offering therapeutic options for patients and continuing our leading research and development efforts in pursuit of breakthrough therapies in the fight against MS.
Sincerely,
Alfred Sandrock, MD, PhD
Senior Vice President, Neurology Research and Development
Less
Recent News About TYSABRI®
FDA Approves TYSABRI® for the Treatment of Moderate-to-Severe Crohn's Disease (1/14/2008)
Biogen Idec and Elan Provide Update on Utilization, Safety and Total Patient Exposure of TYSABRI® in Patients with Multiple Sclerosis (1/7/2008)
CHMP Adopts Negative Opinion on Appeal on European Application for Natalizumab for The Treatment of Crohn's Disease (11/16/2007)
Elan and Biogen Idec Announce That FDA Will Extend Regulatory Review Period for TYSABRI® for Crohn's Disease (10/15/2007)
New TYSABRI® Data to be Presented at the European Committee for Treatment and Research in MS (10/11/2007)
Biogen Idec and Elan Provide Update on Utilization and Safety of TYSABRI® in Patients with MS (10/11/2007)
TYSABRI® Demonstrates Significant Health-Related Quality-of-Life Improvements for Multiple Sclerosis Patients in Study Published in Annals of Neurology (8/20/2007)
Joint FDA Advisory Committee Recommends Approval of TYSABRI® for the Treatment of Moderate to Severe Crohn's Disease (7/31/2007)
TYSABRI® Celebrates One-Year Anniversary as a Treatment for Multiple Sclerosis (7/23/2007)
Elan and Biogen Idec Preparing to Appeal Ruling on European Application for Natalizumab for the Treatment of Crohn's Disease (7/19/2007)
Elan and Biogen Idec Announce a FDA Advisory Committee Meeting to Review TYSABRI® for the Treatment of Crohn's Disease (5/29/2007)
Data Presented at the American Academy of Neurology's Annual Meeting Provide Update on Utilization and Safety of TYSABRI® in Patients with Multiple Sclerosis (5/3/2007)
2006 News Archive
2005 News Archive
