AstraZeneca’s Ultomiris (ravulizumab-cwvz) Receives the US FDA’s Approval for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD)
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- 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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
