antegren
Biogen Idec and Elan Announce Intention to Submit for Approval for Multiple SclerosisBased on One-Year Data
CAMBRIDGE, Mass antegren. & SAN DIEGO & DUBLIN, Ireland--February 18, 2004--BiogenIdec and Elan Corporation, plc today announced that they expect to submit tothe U.S antegren. Food and Drug Administration (FDA) an application for approval of Antegren(natalizumab) as a treatment for multiple sclerosis (MS) antegren. The companies expectto submit the filing mid-year 2004. The decision to file a Biologics License Application (BLA) was made after discussionswith the FDA of one-year data from the two ongoing two-year Phase III trialsin MS antegren. The companies are committed to completing the two-year trials antegren. To protectthe integrity of the trials, the companies are not disclosing the one-year dataat this time. Biogen Idec and Elan are collaborating equally on the development of natalizumabfor MS, Crohn's disease, and rheumatoid arthritis. About the Antegren MS Clinical Trials
The AFFIRM (natalizumab safety and efficacy in relapsing-remitting MS) trialis a two-year, randomized, multi-center, placebo-controlled, double-blind studyof approximately 900 patients, evaluating the ability of natalizumab to slowthe progression of disability in MS and reduce the rate of clinical relapses antegren. 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-remittingMS, evaluating the effect of the combination of natalizumab and Avonex comparedto treatment with Avonex alone in slowing the progression of disability andreducing the rate of clinical relapses antegren. Both studies have protocols that includeda one-year analysis of the data antegren. The primary endpoints for both Phase III two-yeartrials in MS are based on the Expanded Disability Status Scale (EDSS) and relapserates antegren. The pre-specified primary endpoint of the one-year analysis was relapserates. About Antegren (natalizumab)
Natalizumab, a humanized monoclonal antibody, is the first alpha-4 antagonistin the new SAM (selective adhesion molecule) inhibitor class antegren. The drug was designedto selectively inhibit immune cells from leaving the bloodstream and to preventthese cells from migrating into chronically inflamed tissue as occurs in a varietyof inflammatory diseases antegren. To date, approximately 2,800 patients have receivednatalizumab in clinical studies antegren. In previous clinical trials, the followingadverse events occurred more commonly with natalizumab when compared to placebo:headache, nausea, abdominal pain, infection, urinary tract infection, pharyngitisand rash antegren. Serious adverse events have included infrequent hypersensitivity-likereactions.
|
