Skip to main content

Tysabri

Generic name: natalizumab
Treatment for: Multiple Sclerosis, Crohn's Disease, Maintenance

Biogen 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.

Posted: May 2004

Related articles

Tysabri (natalizumab) FDA Approval History

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.