Biogen and Elan announced today they have submitted a Biologics License Application to the US Food and Drug Administration for the approval of antegren for treating multiple sclerosis (MS).
The submission includes one-year data from two ongoing Phase III trials. The companies are not yet disclosing the one-year data to protect the integrity of the trials.
"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 Dr Lars Ekman, executive vice-president and president, research & development, Elan.