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