Biogen Idec and Elan Corporation, plc announced that they have submitted a Biologics License Application (BLA) to the US 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.