Elan said this morning that US regulators had approved its new once-a-month multiple sclerosis drug.
Tysabri, developed by Elan and Biogen and formerly called Antegren, is the first kind of drug to prevent inflamed cells from escaping into the brain, where they can cause unpredictable neurological problems. It is also the first drug for the disease that is given once a month intravenously, as opposed to more frequent injections.
Its approval by the US Food and Drug Administration had been widely expected and the move clears the way for the launch of a product which is crucial to Elan's future.
The US FDA granted accelerated approval for Tysabri following one year data from two phase 3 studies, a monotherapy trial and an add-on trial.
'Tysabri is a significant breakthrough for patients with MS,' commented Elan's President and Chief Executive Office Kelly Martin.
'The approval of Tysabri, with its unique mechanism of action and new level of efficacy, has the potential to make a genuine difference in the lives of patients and families who struggle with the debilitating effects of this disease,' he added.
Elan shares closed down three cent at €20.87 in Dublin, having earlier risen as much as 3%.
