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Alexion's Ultomiris (Ravulizumab-Cwvz) Receives FDA Approval in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

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Alexion's Ultomiris (Ravulizumab-Cwvz) Receives FDA Approval in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

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  • The approval is based on P-III study results assessing of Ultomiris (IV qw- q8w) vs Soliris in 441 patients who were not treated with inhibitors or Soliris with patiparoxysmal nocturnal hemoglobinuria (PNH)
  • The study demonstrated a non-inferiority data showing biosimilarity of Ultomiris to Soliris q2w with safe and well tolerated profile
  • Ultomiris (ravulizumab-cwvz) is a mAb- used for targeting C5 protein in immune system and has received its expected PDUFA date 18 Feb- 2019 by the US FDA
Ref: Alexion| Image: Alexion

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