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.
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