Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced five-times as many multiple sclerosis (MS) patients taking TYSABRI® (natalizumab) were free from disease activity versus placebo in the overall patient population. Results from this retrospective analysis showed that two years after beginning treatment with TYSABRI, 37 percent of patients remained free of disease activity, compared to seven percent of placebo-treated patients. Sixty-four percent of patients showed no sign of relapse or sustained disability progression and 58 percent were free of radiological disease activity. Both of these measures were used to define freedom from disease activity in this analysis of the AFFIRM clinical trial. These data were published online today and in the March 2009 issue of The Lancet Neurology.
The analysis also suggests that the efficacy of TYSABRI may increase over time. The data show the proportion of MS patients who were free of disease activity in the TYSABRI group were greater in the second year than in the first year, while the number of MS patients in a placebo group free of disease activity stayed about the same in the second year. "
Natalizumab is the first therapy to show a robust effect on a composite of disease measures for a two-year time period. These data are encouraging because they suggest that disease remission might become an increasingly attainable goal in MS treatment," said one of the study's authors, Steven Galetta, M.D., professor of neurology, University of Pennsylvania School of Medicine. "The ultimate treatment goal in MS, as with many other autoimmune diseases, is to help patients remain symptom free for as long as possible."
"Since we first discovered TYSABRI in our labs, we have been confident in the product's efficacy and the impact it can have on improving the lives of patients," said Carlos V. Paya, MD, PhD, president of Elan.
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