Elan drug Tysabri gets EC go-ahead

Elan Corporation plc and Biogen Idec today announced that they received approval from the European Commission to market Tysabri as a treatment for multiple sclerosis (MS).

The drug delays the progression of the disability and reduces the frequency of relapses.

The 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.

"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.