The approval was granted based on the results from the P-III (CHAMPION-NMOSD) clinical trial evaluating the safety & efficacy of Ultomiris vs PBO (external; (PREVENT) trial) in patients (n=58) with AQP4 Ab+ NMOSD for a duration of 73wks. The 1EP of the study was time to first adjudicated, on-trial relapse
The study met its 1EP as 0 vs 20 patients depicted adjudicated relapse during the 73.5wks. follow-up period thereby showing a significantly reduced relapse risk along with a safety profile consistent with those of eculizumab & ravulizumab
Ultomiris is a long-acting C5 complement inhibitor that has also been approved in the US & EU for indications incl. gMG, PNH & aHUS
Ref: AstraZeneca | Image: AstraZeneca
Related News:- AstraZeneca’s Ultomiris (ravulizumab) Receives the MHLW’s Approval for the Prevention of Relapses in Patients with NMOSD
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