AstraZeneca’s Ultomiris (ravulizumab) Receives the MHLW’s Approval for the Prevention of Relapses in Patients with NMOSD
Shots:
- The MHLW has approved Ultomiris (C5 complement inhibitor) for the prevention of relapses in patients with AQP4 Ab+ neuromyelitis optica spectrum disorder (NMOSD) incl. neuromyelitis optica
- The approval was based on the P-III trial (CHAMPION-NMOSD) evaluating Ultomiris in 58 patients across North America, the EU, Asia-Pacific & Japan. The trial met its 1EPs of time to first on-trial relapse as confirmed by an independent adjudication committee, zero relapses were seen with a median treatment duration of 73wks., 98.6% relapse risk reduction & continuing through a median duration of 90wks.
- The safety & tolerability were consistent with prior studies & real-world use with no new safety signals. The results were published in the Annals of Neurology
Ref: AstraZeneca | Image: AstraZeneca
Related News:- AstraZeneca’s Ultomiris (ravulizumab) Receives EC’s Approval for the Treatment of Neuromyelitis Optica Spectrum Disorder in EU
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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.
