TysabriTreatment for Multiple Sclerosis, Crohn's Disease -- Maintenance
FDA Accepts Biologics License Application for Antegren for Multiple Sclerosis
CAMBRIDGE, Mass. & SAN DIEGO & DUBLIN, Ireland, July 26, 2004 - Biogen Idec and Elan Corporation, plc announced today that the U.S. Food and Drug Administration (FDA) has formally accepted their Biologics License Application (BLA) for Antegren (natalizumab). In June 2004, the FDA designated natalizumab for Priority Review and Accelerated Approval for the treatment of multiple sclerosis (MS). Acceptance of a filing indicates that the FDA has determined that the application is complete and permits a substantive review.
The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need. Based on the FDA's designation of Priority Review for natalizumab in MS, the companies anticipate action by the Agency approximately six months from the submission date, rather than 10 months for a standard review. On May 25, 2004, the companies announced they had previously submitted the BLA for the approval of natalizumab for MS.
The FDA's review of natalizumab will be based on one-year data from two ongoing Phase III trials, AFFIRM (natalizumab safety and efficacy in relapsing-remitting MS) and SENTINEL (safety and efficacy of natalizumab in combination with AVONEX(R) (Interferon beta-1a)), which evaluate the ability of natalizumab to slow the progression of disability and reduce the rate of clinical relapses in patients with relapsing-remitting MS. The companies are committed to completing these two-year trials.
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.
Natalizumab, a humanized monoclonal antibody, is the first alpha-4 antagonist in the new selective adhesion molecule (SAM) inhibitor class. It is designed to inhibit the migration of immune cells into tissues 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).
About Biogen Idec
Biogen Idec (NASDAQ: BIIB) 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.
Elan Corporation, plc (NYSE: ELN) 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.
Posted: July 2004
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- Elan and Biogen Idec Announce That FDA Will Extend Regulatory Review Period for Tysabri for Crohn's Disease - October 15, 2007
- Joint FDA Advisory Committee Recommends Approval of Tysabri for the Treatment of Moderate to Severe Crohn's Disease - August 1, 2007
- Tysabri Approved for Multiple Sclerosis - November 23, 2004
- Biogen Idec and Elan Submit Biologics License Application to the FDA for Approval of Antegren for Multiple Sclerosis Based on One-Year Data - May 25, 2004
- Biogen Idec and Elan Announce Intention to Submit for Approval for Multiple Sclerosis Based on One-Year Data - February 18, 2004