Elan has received approval from the European Commission to sell its suspended multiple sclerosis drug Tysabri. The drug will be available in Ireland from next month.
This follows approval earlier this month for the drug to return to US shelves, with some restrictions. The drug had been withdrawn in February 2005 after the deaths of two patients involved in trials of the drug from a rare brain disease, PML.
Elan and its partner on Tysabri, Biogen Idec, said in a statement this morning that the EU approval was based on a submission that included two year phase three clinical trial data, findings from a comprehensive safety evaluation, suggested labelling and a risk management plan to inform doctors and patients of the benefits and risks of the drug.
When Tysabri was removed from the market last year, Elan shares fell by 70% in one day's trading.
'This decision means that patients in Europe who are suffering from this chronic, debilitating disease now have an effective new treatment alternative, ' commented Kelly Martin, President and CEO of Elan.
Elan shares closed down 52 cent at €12.73 in Dublin.
