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Alexion’s Ultomiris (ravulizumab) Receives the Health Canada’s Approval for Generalized Myasthenia Gravis

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Alexion’s Ultomiris (ravulizumab) Receives the Health Canada’s Approval for Generalized Myasthenia Gravis

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  • The approval was based on the P-III trial (CHAMPION-MG) evaluating Ultomiris in a ratio (1:1) in 175 patients who are AChR Ab+ for 26wks. across the EU, North America, Asia-Pacific & Japan. Eligible patients will continue into an OLE period, following the completion of the randomized control period
  • The results showed that Ultomiris (C5 complement inhibitor) was superior to PBO for the 1EPs of change from baseline in MG-ADL total score @26wks. & the safety profile was comparable to PBO & was consistent with P-III trials. The results were published in NEJM & presented at AAN 2022
  • The results also showed an early effect & lasting improvement in activities of daily living & can reduce treatment burden with dosing q8w. Ultomiris is also being evaluated for hematology & neurology indications

Ref: Globenewswire  | Image: Alexion

Related News:- AstraZeneca Presents P-III (CHAMPION-NMOSD) Trial Results of Ultomiris (ravulizumab) for Neuromyelitis Optica Spectrum Disorder at ECTRIMS 2022

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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