Shots:

• The approval is based on the P-III trial that evaluates Ultomiris (q4w/q8w) vs Soliris in children & adolescents aged ≤18yrs. with PNH
• The interim result showed that the therapy was effective in achieving C5 complement inhibition @26wks. & demonstrated safety & efficacy profile with reduced dosing frequency- no treatment-related SAEs & no patients discontinued treatment were observed during the primary evaluation period or experienced breakthrough hemolysis
• The therapy is approved in the US for adults & children aged ≥1mos. with PNH & in the EU for adults & children who experience hemolysis with clinical symptoms & who are clinically stable after being treated with Soliris for the past 6mos.

  | Ref: AstraZeneca | Image: Stat News