Biogen Idec and Elan Announce Intention to Submit Antegren for Approval for Multiple Sclerosis in Europe
Tuesday March 23, 2:30 am ET
CAMBRIDGE, Mass., SAN DIEGO, Calif., & DUBLIN, Ireland--(BUSINESS WIRE)--March 23, 2004--Biogen Idec and Elan Corporation, plc today announced that they intend to submit to the European Agency for the Evaluation of Medicinal Products (EMEA) an application for approval of ANTEGREN® (natalizumab) as a treatment for multiple sclerosis (MS). The companies expect to submit the filing in the summer of 2004.
The decision to file was made after discussion with European regulatory officials, based on one-year data from the ongoing Phase III trials in MS. The companies are committed to completing these two-year trials. To protect the integrity of these 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 in MS, Crohn's disease, and rheumatoid arthritis. In February, the two companies announced they expect to submit a Biologics License Application (BLA) for natalizumab in MS with the U.S. Food and Drug Administration (FDA) mid-year 2004.
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. |
