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

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

Alexion Collaborates with Caelum Biosciences for its CAEL-101 to Treat Light Chain (AL) Amyloidosis

Shots:
  • 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

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

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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