Tysabri
natalizumab
Treatment for Multiple Sclerosis, Crohn's Disease -- MaintenanceBiogen Idec and Elan Announce Intention to Submit for Approval for Multiple Sclerosis Based on One-Year Data
CAMBRIDGE, Mass. & SAN DIEGO & DUBLIN, Ireland--February 18, 2004--Biogen Idec and Elan Corporation, plc today announced that they expect to submit to the U.S. Food and Drug Administration (FDA) an application for approval of Antegren (natalizumab) as a treatment for multiple sclerosis (MS). The companies expect to submit the filing mid-year 2004.
The decision to file a Biologics License Application (BLA) was made after discussions with the FDA of one-year data from the two ongoing two-year Phase III trials in MS. The companies are committed to completing the two-year trials. To protect the integrity of the trials, the companies are not disclosing the one-year data at this time.
Biogen Idec and Elan are collaborating equally on the development of natalizumab for MS, Crohn's disease, and rheumatoid arthritis.
About the Antegren MS Clinical Trials
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 (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
studies have protocols that included 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 rates. The pre-specified primary endpoint of the one-year
analysis was relapse rates.
About Antegren (natalizumab)
Natalizumab, a humanized monoclonal antibody, is the first alpha-4
antagonist in the new SAM (selective adhesion molecule) inhibitor
class. The drug was designed to selectively inhibit immune cells
from leaving the bloodstream and to prevent these cells from
migrating into chronically inflamed tissue as occurs in a variety
of inflammatory diseases. To date, approximately 2,800 patients
have received natalizumab in clinical studies. In previous clinical
trials, the following adverse events occurred more commonly with
natalizumab when compared to placebo: headache, nausea, abdominal
pain, infection, urinary tract infection, pharyngitis and rash.
Serious adverse events have included infrequent
hypersensitivity-like reactions.
Source: Elan Corporation, plc
Related Articles:
FDA Approves Tysabri to Treat Moderate-to-Severe Crohn's Disease - January 15, 2008
Tysabri Approved for Multiple Sclerosis - November 23, 2004
FDA Accepts Biologics License Application for Antegren for Multiple Sclerosis - July 26, 2004
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