BioCentury
ARTICLE | Company News

Alexion gains early approval for long-acting PNH therapy

December 21, 2018 11:31 PM UTC

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) received FDA approval for Ultomiris ravulizumab-cwvz (ALXN1210), the biotech's long-acting formulation of Soliris eculizumab, to treat paroxysmal nocturnal hemoglobinuria.

While the approval came nearly two months ahead of the Feb. 18 PDUFA date, Alexion prepared for an early approval scenario and will launch Ultomiris immediately, according to company spokesperson Megan Goulart...