HOME >> MEDICINE >> NEWS
FDA grants accelerated approval of TYSABRI, formerly antegren, for the treatment of MS

Phase III trials at one year demonstrate new level of efficacy 66% reduction in rate of relapses seen in AFFIRM monotherapy trial

Cambridge, MA; San Diego, CA; Dublin, Ireland November 23, 2004 Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today that the U.S. Food and Drug Administration (FDA) has approved TYSABRI (natalizumab), formerly referred to as ANTEGREN, as treatment for relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical relapses. FDA granted Accelerated Approval for TYSABRI following Priority Review based on one-year data from two Phase III studies, the AFFIRM monotherapy trial and the SENTINEL add-on trial with AVONEX(Interferon beta-1a).

TYSABRI, the first humanized monoclonal antibody approved for the treatment of MS, inhibits adhesion molecules on the surface of immune cells. Research suggests TYSABRI works by preventing immune cells from migrating from the bloodstream into the brain where they can cause inflammation and potentially damage nerve fibers and their insulation.

"TYSABRI is a powerful and innovative therapy that offers new hope for hundreds of thousands of people living with MS," said James C. Mullen, chief executive officer, Biogen Idec. "We believe TYSABRI will revolutionize the treatment of MS and become the leading choice for patients and physicians."

"TYSABRI is a significant breakthrough for patients with MS," said Kelly Martin, president and chief executive officer, Elan. "The approval of TYSABRI, with its unique mechanism of action and new level of efficacy, has the potential to make a genuine difference in the lives of patients and families who struggle with the debilitating effects of this disease."

Results of the AFFIRM Monotherapy Trial

AFFIRM is a two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide, in which patients were
'"/>

Contact: Amy Losak
646-935-9317
Ketchum
23-Nov-2004


Page: 1 2 3 4 5 6

Related medicine news :

1. UNH launches 2nd spinout company with NIH grants
2. Disease testing for immigrants: Discrimination disguised as public health policy
3. US FDA grants full approval to DOXIL(R) following submission of phase III data
4. Four teams awarded inaugural translational cancer research grants
5. Immigrants, beware: Living in the United States is fattening
6. Prevalence of obesity among immigrants increases with longer residency in US
7. Dana-Farber receives CDC grants to develop health promotion/prevention programs in the work place
8. Speech recognition experts at OGI School of Science & Engineering receive nearly $700,000 in grants
9. Should compulsory screening of immigrants be part of UK public health policy?
10. NIH grants support health disparities biomedical research
11. NCCAM awards planning grants for International Centers for Research

Post Your Comments:
(Date:5/22/2013)... 22, 2013 People in the United States ... to water shortages. In much of the world, water shortages ... advocate, Sharon Kleyne. She warns against taking water for granted ... is available so easily in the United States. , Sharon ... Water radio show, heard live or by podcast on World ...
(Date:5/22/2013)... Bodybuilding.com is giving back to those who have ... be donating $1 from EVERY purchase made between 12:01am – ... grateful for the men and women who have served our ... founder of Bodybuilding.com. “It’s an honor to give back to ... USA is an amazing organization that supports our nation’s veterans ...
(Date:5/22/2013)... May 22, 2013 Twenty student-led startup ... year participating in an intensive startup accelerator designed to ... or services and create local jobs as part of ... year the Edson initiative offers approximately 20 student teams ... mentorship and training to launch their for-profit, more-than-profit or ...
(Date:5/22/2013)... Researchers in genomic health disparities from the University ... University School of Medicine have teamed up to hold ... Eliminate Health Disparities in Genomic Medicine." The theme ... nonprofits, business and government to reduce these disparities. , ... United States, individuals within underserved groups continue to be ...
(Date:5/22/2013)... report that hospitals may be reaping enormous income ... preventable bloodstream infections contracted in their intensive care ... online in the American Journal of Medical ... patient who develops an avoidable central line-associated bloodstream ... care for than a similar infection-free patient. Moreover, ...
Breaking Medicine News(10 mins):Health News:Water Advocate Sharon Kleyne Announces Water Conservation Appreciation 2Health News:In the Spirit of Memorial Day, Bodybuilding.com is Donating a Portion of Their Sales to Hire Heroes 2Health News:ASU Announces Edson Student Entrepreneur Initiative’s 2013-2014 Cohort 2Health News:ASU Announces Edson Student Entrepreneur Initiative’s 2013-2014 Cohort 3Health News:ASU Announces Edson Student Entrepreneur Initiative’s 2013-2014 Cohort 4Health News:ASU Announces Edson Student Entrepreneur Initiative’s 2013-2014 Cohort 5Health News:ASU Announces Edson Student Entrepreneur Initiative’s 2013-2014 Cohort 6Health News:ASU Announces Edson Student Entrepreneur Initiative’s 2013-2014 Cohort 7Health News:ASU Announces Edson Student Entrepreneur Initiative’s 2013-2014 Cohort 8Health News:ASU Announces Edson Student Entrepreneur Initiative’s 2013-2014 Cohort 9Health News:Why We Can't Wait: Conference to Eliminate Health Disparities in Genomic Medicine 2Health News:Hospitals profit when patients develop bloodstream infections 2Health News:Hospitals profit when patients develop bloodstream infections 3Health News:Hospitals profit when patients develop bloodstream infections 4
(Date:5/22/2013)... 22, 2013   Upsher-Smith Laboratories, Inc. ... its global Phase III clinical trial for ... for the management of epilepsy in adults, ... is specifically engineered to provide convenient once-daily ... levels observed with currently available treatment options.  ...
(Date:5/22/2013)...   Life Line Screening  (LLS), a leading ... creation of a unique partnership with MCM Solutions ... is a population health management organization. LLS will provide ... These important expanded services will help MCM and its ... reduces cost of care when individuals are able to ...
(Date:5/22/2013)... -- Ranbaxy Laboratories Limited (hereafter, Ranbaxy), a subsidiary ... announced on May 22 the actions that Ranbaxy ... conduct under prior management ( ... to support Ranbaxy in its efforts to address ... led to the investigations by the U.S. Department ...
Breaking Medicine Technology:Upsher-Smith Successfully Completes Phase III Study Of USL255 (Extended-Release Topiramate) For Adjunctive Treatment Of Epilepsy In Patients With Refractory Partial-Onset Seizures 2Upsher-Smith Successfully Completes Phase III Study Of USL255 (Extended-Release Topiramate) For Adjunctive Treatment Of Epilepsy In Patients With Refractory Partial-Onset Seizures 3Upsher-Smith Successfully Completes Phase III Study Of USL255 (Extended-Release Topiramate) For Adjunctive Treatment Of Epilepsy In Patients With Refractory Partial-Onset Seizures 4Life Line Screening and MCM Solutions for Better Health Announce New Partnership 2
Cached News: