Alexion's submits Soliris MAA to EMEA

The USA's Alexion Pharmaceuticals says that its wholly-owned subsidiary, Alexion Europe, has submitted a market authorization application to the European Medicines Agency (EMEA) for Soliris (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria, a rare, life-threatening genetic blood disorder. If accepted, Alexion anticipates that the evaluation by the EMEA will commence in the fourth quarter.

The MAA submission will be reviewed under the centralized licensing procedure which, if approval is granted, provides a marketing license valid in all 25 member states of the European Community. The EMEA has determined that the Accelerated Assessment Procedure can be utilized for the Soliris application review.