Biogen, Elan give update on trials, safety study for multiple sclerosis drug Tysabri

By Elaine Rigoli

Tampa, Fla., March 1 - Biogen Idec and Elan Corp. announced Wednesday that two-year results from the two phase 3 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.

Data from the phase 3 Affirm monotherapy trial, the phase 3 Sentinel trial in which Tysabri was added to Avonex (Interferon beta-1a) therapy, and the safety evaluation were submitted to the Food and Drug Administration in a supplemental Biologics License Application in September, according to a company news release.

The sBLA is under priority review, and the companies anticipate action from the FDA in late March. Similar data have been submitted to European regulatory authorities.

The Affirm data 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 a placebo, the release said.

The treatment also resulted in sustained and statistically significant reductions in brain lesion activity as measured by MRI.

Likewise, the two-year Sentinel 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, concluded there were no new confirmed cases of PML in patients treated with Tysabri beyond the three previously reported by the companies, the release said.

Located in Cambridge, Mass., Biogen creates new standards of care in oncology, neurology and immunology.

Elan is a neuroscience-based biotechnology company located in Dublin, Ireland.

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