Alexion’s Ultomiris (ravulizumab) Receives EC’s Approval for Expanded Use to Treat Paroxysmal Nocturnal Haemoglobinuria

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.

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