Tysabri
natalizumab
Treatment for Multiple SclerosisBiogen Idec and Elan Submit Biologics License Application to the FDA for Approval of Antegren for Multiple Sclerosis Based on One-Year Data
CAMBRIDGE, Mass., SAN DIEGO, Calif. & DUBLIN, Ireland, May 25, 2004 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today that they have submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of Antegren (natalizumab) for the treatment of multiple sclerosis (MS).
The submission includes one-year data from two ongoing Phase III trials. The companies are committed to completing these two-year trials. In order to protect the integrity of the trials, the companies are not disclosing the one-year data at this time.
"Based on the one-year analysis from our Phase III studies, which include more than 2,100 patients, we believe that natalizumab has the potential to become an important new therapy for MS," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "Natalizumab's novel mechanism of action represents an innovative approach to treating MS."
"This submission represents a significant milestone for Elan and Biogen Idec and demonstrates our continued commitment to providing a new treatment option for the more than one million patients experiencing the debilitating effects of MS," said Lars Ekman, MD, executive vice president and president, Research & Development, Elan. "We look forward to working with the FDA throughout the review process to make natalizumab available to patients who may be in need."
MS is a chronic disease of the central nervous system that affects approximately 400,000 people in North America and approximately one million people worldwide. It is a disease that affects more women than men, with onset typically between 20 and 40 years of age. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.
About the MS Clinical Trials for Antegren
The AFFIRM (natalizumab safety and efficacy in relapsing-remitting
MS) trial is a two-year, randomized, multi-center,
placebo-controlled, double-blind study of approximately 900
patients, evaluating the ability of natalizumab to slow the
progression of disability in MS and reduce the rate of clinical
relapses. The SENTINEL (safety and efficacy of natalizumab in
combination with AVONEX(R) (Interferon beta-1a)) trial is a
two-year, randomized, multi-center, placebo-controlled,
double-blind study of approximately 1,200 patients with
relapsing-remitting MS, evaluating the effect of the combination of
natalizumab and AVONEX compared to treatment with AVONEX alone in
slowing the progression of disability and reducing the rate of
clinical relapses. Both study protocols provided for a one-year
analysis of the data. The primary endpoints for both Phase III
two-year trials in MS are based on the Expanded Disability Status
Scale (EDSS) and relapse rate. The pre-specified primary endpoint
of the one-year analysis was relapse rate.
About Antegren (natalizumab)
Natalizumab, a humanized monoclonal antibody, is the first alpha-4
antagonist in the new selective adhesion molecule (SAM) inhibitor
class. The drug is designed to inhibit the migration of immune
cells into chronically inflamed tissue where they may cause or
maintain inflammation. To date, approximately 2,800 patients have
received natalizumab in clinical trials, and the safety profile
continues to support further development. In placebo-controlled
trials to date, in both Crohn's disease (CD) and MS, the most
commonly reported adverse events in either group were headache,
fatigue and nasopharyngitis.
Biogen Idec and Elan are collaborating equally on the development of natalizumab in MS, CD, and rheumatoid arthritis (RA). The companies intend to submit an application for drug approval in Europe for MS by the end of the second quarter of 2004.
About Biogen Idec
Biogen Idec creates new standards of care in oncology 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
that is focused on discovering, developing, manufacturing and
marketing advanced therapies in neurology, autoimmune diseases, and
severe pain. Elan shares trade on the New York, London and Dublin
Stock Exchanges.
For additional information about the company, please visit www.elan.com.
Related Articles:
Tysabri Biogen Idec / Elan Corporation, plc - Treatment for Multiple Sclerosis - November 23, 2004
FDA Accepts Biologics License Application for Antegren for Multiple Sclerosis - July 26, 2004
Biogen Idec and Elan Announce Intention to Submit for Approval for Multiple Sclerosis Based on One-Year Data - February 18, 2004
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