On Feb. 18, 2004, Elan and Biogen Idec announced their plan to submit a Biologics License Application (BLA) for Antegren (natalizumab) to the U.S. FDA for the treatment of multiple sclerosis (MS) by the middle of this year. The surprise announcement was made after a consultation with the FDA of the drug’s one-year data from the two ongoing two-year Phase III trials in MS. The companies are committed to completing two-year trials and would not disclose the one-year data at this time, citing the necessity to protect the integrity of the results of the two-year trials, which will be submitted ... Read more