EMA's CHMP Backs AstraZeneca's Drug For Rare Blood Disorder In Children

AstraZeneca Plc AZN said that the European Medicines Agency (EMA) has recommended approving a medicine from its recently acquired Alexion for a rare, deadly blood disorder in children and adolescents aged up to 18 years.
Ultomiris has been given a positive opinion for paroxysmal nocturnal hemoglobinuria (PNH) by the human medicines committee of the EMA, and it follows the U.S. approval for adolescents in June.
The EMA endorsement includes children with a bodyweight of 10 kg or above and those clinically stable patients after being treated with another Alexion drug, Soliris, for at least the past six months.
Ultomiris is an improved version of Alexion's best-selling drug Soliris, which is used against a range of rare immune disorders, including PNH, where the body's immune system attacks its red blood cells, causing anemia and blood clots.
Price Action: AZN shares are down 1.55% at $57.33 during the premarket session on the last check Friday.
Related content: Benzinga's Full FDA Calendar.