Biogen Idec and Elan Corporation, plc announced that they received approval from the European Commission to market Tysabri (natalizumab) as a treatment for relapsing remitting multiple sclerosis (MS) to delay the progression of disability and reduce the frequency of relapses.
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.
The approval was based on a submission that included Tysabri two-year phase III clinical trial data, findings from the comprehensive safety evaluation, suggested labelling, 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.
"Today marks an important step forward for the European MS patient community," said James C. Mullen, chief executive officer, 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."
"This decision means that patients in Europe who are suffering from this chronic, debilitating disease now have an effective new treatment alternative," said Kelly Martin, President and chief executive officer, Elan.
This action follows a recommendation made by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), which on April 28, 2006, issued a positive opinion recommending marketing authorization for Tysabri.