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Alexion's Ultomiris (Ravulizumab) Receives European Commission's Marketing Authorization for Paroxysmal Nocturnal Hemoglobinuria in Adults

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Alexion's Ultomiris (Ravulizumab) Receives European Commission's Marketing Authorization for Paroxysmal Nocturnal Hemoglobinuria in Adults

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  • The approval is based on two P-III studies assessing Ultomiris (q8w) in 440+ patients with PNH prior not treated with complement inhibitor or treated with Soliris (eculizumab- q2w) for at least past six months
  • The two P-III studies resulted in non-inferiority to the efficacy of Soliris on all 11 1EPs and 2EPs with similar safety profile as Soliris. Additionally- Ultomiris provided complete C5 inhibition and eliminated breakthrough hemolysis allied with incomplete C5 inhibition
  • Ultomiris is a mAb targeting C5 protein and has received FDA’s approval on Dec 21- 2018 & MHLW’s approval on Jun 18- 2019 for the treatment of PNH in adults. Ultomiris reduces     the number of infusions/years from 26 to 6/7 which resulted in reduction of burden on patients

Click here to read full press release/ article | Ref: Alexion | Image: RTE


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