Avonex label change

FDA approves revised labeling for Biogen's Avonex Nov. 12 indicating a lower occurrence of neutralizing antibodies to Avonex than previously demonstrated in Phase III trials. The revised label places the rate of occurrence of neutralizing antibodies at 5% (13 of 261 patients), down from 24%, based on changes in Avonex' manufacturing process. Labeling for Serono's Rebif carries a 24% rate of neutralizing antibodies, although labeling for both products notes that the clinical significance of neutralizing antibodies is unknown, and that rates cannot be compared...