Tysabri was pulled from the US market last year after three patients taking the drug developed progressive multifocal leukoencephalopathy (PML), a rare and usually fatal brain disease. The drug was recently relaunched in the US, albeit with more specific labelling restrictions.
The European approval was based on a submission that included Tysabri two-year phase III clinical trial data, findings from the comprehensive safety evaluation, suggested labeling, and a risk management plan designed to inform physicians and patients of the benefits and risks of Tysabri treatment and minimize the potential risk of progressive multifocal leukoencephalopathy (PML) and other opportunistic infections.
Tysabri is indicated as a single disease modifying therapy in highly active relapsing remitting MS for patients with high disease activity despite treatment with a beta-interferon or in patients with rapidly evolving severe relapsing remitting MS.
“Today marks an important step forward for the European MS patient community,” said James Mullen, CEO, Biogen Idec. “Tysabri represents one of the most significant advances in MS treatment in nearly 10 years and provides patients living with this disabling disease an important new therapeutic choice.”