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

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

Shots:

  • 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