Alexion’s Ultomiris (ravulizumab) Receives EC’s Approval for Atypical Hemolytic Uremic Syndrome

Alexion’s Ultomiris (ravulizumab) Receives EC’s Approval for Atypical Hemolytic Uremic Syndrome

Shots:

  • The EC approval is based on two ongoing studies (one in adults & other in children) assessing Ultomiris in patients with aHUS. A total of 18/21 & 56/58 complement inhibitor treatment-naïve children & adults were enrolled and included in the interim analysis respectively
  • @26wks and @52wks: Complete TMA Response (54% & 77.8% and 61% & 94%); normalization of platelet count (84% & 94% and 86% & 94%); normalization of LDH (77% & 90% and 84% & 94%); improved kidney function (59% & 83% and 63% & 94%) respectively. 10 pediatric patients who were Soliris-experienced demonstrate that switching to Ultomiris maintained disease control with no apparent impact on safety
  • Ultomiris is the first and only long-acting C5 complement inhibitor, administered every month, reducing the treatment burden in adults and children and has received the US FDA’s approval in Oct’2019 while the approval  in Japan in under review for aHUS

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

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