Benzinga | Jul 26, 2021 08:52AM EDT

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

* AstraZeneca Plc (NASDAQ: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.