EC extends label of Alexion's Soliris

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) gained $5.31 to $182.68 on Friday after the European Commission approved an expanded label for Soliris eculizumab.

Soliris' label now includes treatment of transfusion-naive patients with paroxysmal nocturnal hemoglobinuria (PNH). Previously, the label said the evidence of Soliris' clinical benefit was limited to transfusion-experienced PNH patients. Alexion said the new approval was based on data from a PNH Registry that showed transfusion-naive patients treated with Soliris had a significant reduction in hemolysis and clinical symptoms associated with high disease activity. The company declined to give an estimate of the fraction of the patient population that is transfusion-naive. ...