Alexion’s Ultomiris (ravulizumab) Receives MHLW’s Marketing Authorization to Treat Paroxysmal Nocturnal Hemoglobinuria in Adults

Alexion’s Ultomiris (ravulizumab) Receives MHLW’s Marketing Authorization for Paroxysmal Nocturnal Hemoglobinuria in Adults

Shots:

  • The approval is based on two P-III studies results assessing Ultomiris (IV, q8w) in 441 patients with PNH with no prior treatment with complement inhibitor or who had been stable on its Soliris (eculizumab)
  • The two P-III studies demonstrated that Ultomiris is non-inferior to the Soliris (q2w) on all 11 endpoints. Additionally, Ultomiris resulted in immediate and complete C5 inhibition, sustained for 8wks. and eliminates breakthrough hemolysis related with incomplete C5 inhibition
  • Ultomiris is a long-acting C5 inhibitor, approved in the US & Japan for PNH in adults with its expected sBLA approval in the US and plans to submit sBLA in the EU and Japan in H2’19 for the atypical hemolytic uremic syndrome (aHUS)

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