The EC has approved Ultomiris as an add-on to standard therapy for gMG in adult patients who are AChR Ab+
The EC’s decision was based on the P-III (CHAMPION-MG) trial evaluating Ultomiris in a ratio (1:1) in 175 adult patients with gMG across North America, EU, Asia-Pacific & Japan for 26wks. The results showed that the therapy was superior to PBO in the 1EPs of change from baseline in MG-ADL total score @26wk. clinical benefits were seen @60wks. in prolonged follow-up results from OLE
Reduction in treatment burden with dosing q8w & the results were published in NEJM Evidence, improvement in daily activities in patients with milder symptoms. The safety profiles were consistent with P-III trials in PNH & aHUS
Ref: AstraZeneca | Image: AstraZeneca
