Alexion’s Ultomiris (ravulizumab) Receives CHMP’s Positive Opinion Recommending its Approval for Children and Adolescents with PNH

 Alexion’s Ultomiris (ravulizumab) Receives CHMP’s Positive Opinion Recommending its Approval for Children and Adolescents with PNH

Shots:

  • The CHMP’s positive opinion is based on a P-III study assessing Ultomiris and showed effectiveness in completing C5 complement inhibition @26wks. for children & adolescents aged ≤18yrs. with PNH
  • The study demonstrated that there is no reported treatment-related sAEs, and no patients discontinued treatment during the primary evaluation period or experienced breakthrough hemolysis
  • The CHMP recommended the expanded use of Ultomiris to include children (with a body weight of ≥10kg) and adolescents with PNH who experience hemolysis with clinical symptoms indicative of high disease activity and for individuals who are clinically stable after being treated with Soliris for the past 6mos.

Click here to­ read full press release/ article | Ref: AstraZeneca | Image: Al Jazeera

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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