by Playfuls Staff |
2nd March 2006
Biogen Idec and Elan Corporation announced that two-year results from the two Phase III clinical trials evaluating TYSABRI (natalizumab) for patients with relapsing forms of multiple sclerosis (MS), as well as data from the comprehensive safety evaluation of the product were published for the first time in this week's issue of The New England Journal of Medicine. The two-year data from the Phase III MS trials were previously presented at [more] U.S. and international medical meetings during 2005.
Data from the Phase III AFFIRM monotherapy trial, the Phase III SENTINEL trial in which TYSABRI was added to AVONEX (Interferon beta-1a) therapy, and the safety evaluation were submitted to the U.S. Food and Drug Administration (FDA) in a supplemental Biologics License Application (sBLA) in September 2005. The sBLA is under Priority Review, and the companies anticipate action from FDA in late March. Similar data have been submitted to European regulatory authorities.
Two-year AFFIRM Phase III monotherapy data published today showed that treatment with TYSABRI reduced the risk of disability progression by 42% (p<0.001), the primary endpoint of the study, and led to a 68% reduction (p<0.001) in the annualized relapse rate compared to placebo. TYSABRI treatment also resulted in sustained and statistically significant reductions in brain lesion activity as measured by MRI. The two-year SENTINEL Phase III data also demonstrated that treatment with TYSABRI in addition to AVONEX had a significant effect on disability progression, relapse rate and brain MRI disease activity compared to AVONEX alone.
Biogen Idec and Elan collaborated with leading experts in MS and progressive multifocal leukoencephalopathy (PML) to complete a safety evaluation of more than 3,000 patients who had received TYSABRI. An Independent Adjudication Committee, established as part of the safety evaluation, today published its findings that concluded there were no new confirmed cases of PML in patients treated with TYSABRI beyond the three previously reported by the companies.
IAC Safety Evaluation
As part of the safety evaluation, the IAC was established to review any suspected cases of PML. The IAC was chaired by Eugene Major, PhD, Chief of the Laboratory of Molecular Medicine and Neuroscience at the National Institute of Neurological Disorders and Stroke at the National Institutes of Health. Highlights of the IAC's findings include:
The safety review was designed to evaluate TYSABRI clinical trial patients and any reports of suspected PML in patients receiving TYSABRI in the commercial setting. Of the 3,826 MS, Crohn's disease (CD) and rheumatoid arthritis (RA) clinical trial patients eligible for the evaluation, 3,389 (89%) participated (2,046 MS patients, 1,343 CD and RA patients).
Of the participating MS patients, 97% were examined with MRI or neurological exam within three months of the last dose, while 91% of CD and RA patients were examined within 6 months of the last dose.
A total of 44 patients were referred to IAC for evaluation, which determined that none of the referred cases met the diagnostic criteria for PML.
