ALXN - European advisory group backs new formulation of Alexion's Ultomiris

Alexion Pharmaceuticals (ALXN) announces that the Committee for Medicinal Products for Human Use ((CHMP)) has adopted a positive opinion, recommending marketing authorization in the European Union for a new 100 mg/mL intravenous ((IV)) advanced formulation of ULTOMIRIS (ravulizumab).ULTOMIRIS 100 mg/mL would constitute 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.European Commission decision anticipated in November 2020.ULTOMIRIS is the first and only long-acting C5 inhibitor administered every eight weeks for the treatment of two ultra-rare diseases—paroxysmal nocturnal hemoglobinuria((PNH)) and atypical hemolytic uremic syndrome ((aHUS)).ALXN has grown around 38% over the past six months.

For further details see:

European advisory group backs new formulation of Alexion's Ultomiris