AstraZeneca’s Ultomiris (ravulizumab) Receives EC’s Approval for the Treatment of Neuromyelitis Optica Spectrum Disorder in EU
Shots:
- The EC has approved Ultomiris (C5 complement inhibitor) for adult patients with anti-aquaporin-4 (AQP4) Ab+ NMOSD
- The approval was based on the results from the P-III trial (CHAMPION-NMOSD) published in the Annals of Neurology evaluating Ultomiris in 58 patients across North America, the EU, Asia-Pacific & Japan which showed that Ultomiris met the 1EPs of time to first on-trial relapse
- Zero relapses were reported in patients with a median treatment duration of 73wks. (98.6% in relapse risk reduction) and continuing through a median duration of 90wks. & the safety & tolerability was consistent with prior studies and real-world use with no new safety signals. The regulatory submissions are under review with multiple health authorities, incl. in the US & Japan
Ref: AstraZeneca | Image: AstraZeneca
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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.
