The FDA decision on Alexion Pharmaceuticals Inc.’s (ALXN) new 100 mg/mL intravenous advanced formulation of Ultomiris is expected on October 11, 2020.Ultomiris in 10 mg/mL IV formulation is approved by the FDA for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) and for the treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS).According to the company, the new proposed formulation requires an infusion time of only 0.4 to 1.3 hours (25 to 75 minutes) while the currently available 10mg/mL IV formulation requires an infusion time, which ranges from 1.3 to 3.3 hours (77 to 194 minutes).The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recently recommended approval of the new 100 mg/mL IV advanced formulation of Ultomiris. The European Medicines Agency’s decision is expected this year. The net product sales of Ultomiris were $251.1 million in the second quarter of 2020, compared to $54.2 million in the year-ago quarter.ALXN closed Friday’s (Sep.25, 2020) trading at $114.43, up 2.15%.