Priority Review for Alexion's long-acting PNH therapy

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) said FDA accepted and granted Priority Review to its BLA for ALXN1210 to treat paroxysmal nocturnal hemoglobinuria. Its PDUFA date is Feb. 18, 2019.

ALXN1210 is a long-acting humanized mAb targeting complement 5 (C5); Alexion already markets C5 inhibitor Soliris eculizumab. Global net sales of Soliris were $3.1 billion in 2017, and accounted for 89% of Alexion's aggregate net product sales. The drug is approved to treat PNH, atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG)...