ALXN - New formulation of Alexion's Ultomiris Ok'd by FDA

The FDA has approved Alexion Pharmaceuticals's (ALXN) Ultomiris (ravulizumab-cwvz) 100 mg/mL intravenous formulation for the treatment of adults with paroxysmal nocturnal hemoglobinuria ((PNH)) and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy, for adult and pediatric patients.ULTOMIRIS 100 mg/mL constitutes an advancement in the treatment experience by reducing average annual infusion times by ~60% compared to ULTOMIRIS 10 mg/mL while delivering comparable safety and efficacy.Atypical HUS is an ultra-rare disease that can cause progressive injury to vital organs, primarily the kidneys, via damage to the walls of blood vessels and blood clots.PNH is a rare blood disease in which the immune system destroys red blood cells.

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New formulation of Alexion's Ultomiris Ok'd by FDA