Alexion Gains Expanded Approval for Blood Disorder Drug
Alexion Pharmaceuticals has received FDA approval for a 100 mg/mL formulation of Ultomiris (ravulizumab-cwvz) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
The Boston, Mass., drugmaker says the new formulation of Ultomiris reduces infusion time by 60 percent vs. the 10 mg/mL version, with patients estimated to spend an annual six hours or fewer undergoing treatment.
PNH is a blood disorder associated with a range of symptoms, such as thrombosis which can lead to organ damage and death. Linked with PNH and other co-morbidities, aHUS can lead to renal failure.
Alexion has filed marketing applications for the new formula with the EU and Japan, and expects a decision from the European Commission next month.