The European Medicines Agency (EMA) has recommended that the multiple sclerosis treatment drug Tysbari should be made available to patients on a restricted basis.
Tysabri was withdrawn from the market early in 2005 after some US patients who had been treated with the drug in combination with other medication developed the brain disease, PML. The decision led to the collapse of Elan's share price.
Since then the regulatory authorities in the US and in Europe have been separately re-examining the clinical trial research data surrounding the drug's original launch.
Today's recommendation will go before the European Commission for final approval. That is expected in June but will limit the use of Tysabri as a single therapy only which will be restricted to patients with an agressive form of Multiple Sclerosis.
Today's annoucement from the EMA could mean Tysabri will launch in Europe before any relaunch in the US where the Food and Drug Administration has still to give final marketing approval.
Elan's share price rose sharply on the news but fell back to end unchanged at €11.65 in Dublin.
