Biogen Idec (NASDAQ: BIIB) and
Corporation, plc (NYSE: ELN) announced results from several studies of TYSABRI
(natalizumab) that demonstrate its efficacy compared to other multiple sclerosis (MS) treatments, provide additional data supporting anti-JC virus (JCV) antibody status stability, and suggest better outcomes when progressive multifocal leukoencephalopathy (PML) is detected early. These data will be presented at the 65th Annual Meeting of the American Academy of Neurology (AAN) in San Diego.
“These new data reinforce our belief in the substantial efficacy TYSABRI has demonstrated at both the early and advanced stages of relapsing forms of MS,” said Alfred Sandrock, M.D., Ph.D., senior vice president, Development Sciences and chief medical officer, Biogen Idec. “We are also encouraged by the consistency in anti-JCV antibody status demonstrated over 18 months, as well as results from our pursuit of additional paths to help mitigate the impact of PML. These combined efforts may allow a more individualized approach when selecting TYSABRI treatment, while helping physicians better understand a patient’s benefit-risk profile.”
Substantial TYSABRI Efficacy Demonstrated Against First-Line Therapies
In an independent statistical analysis led by Timothy Spelman and Helmut Butzkueven, M.D. at the University of Melbourne, with contribution by Fabio Pellegrini and Annie Zhang, TYSABRI demonstrated a significantly lower rate of first relapse compared to interferon beta (IFN) and glatiramer acetate (GA). This propensity-matched analysis was conducted using data from two MS patient registries: TYSABRI Observational Program (TOP) and MSCOMET. The results indicate that relapses were not only more likely to occur in patients taking IFN and GA, but that they occurred more quickly, when compared to patients taking TYSABRI (hazard ratio 2.73, 95 percent confidence interval 2.10-3.55, p<0.001).
Anti-JCV Antibody Stability Data Support Risk Stratification Approach
- Comparison of Patients Treated with Natalizumab and Interferon-Beta/Glatiramer Using Propensity-Matched Multiple Sclerosis Registry Data (P01.211) will be available for viewing on Monday, March 18, 2013 from 2:00 to 6:30 p.m. PDT
To help physicians better identify the most appropriate patients for TYSABRI treatment, Biogen Idec developed a risk stratification approach. This approach assesses each patient’s personal benefit-risk profile based on several factors, including anti-JCV antibody status, which was added to the TYSABRI EU label in 2011 and the U.S. label in 2012.