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
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