AstraZeneca Receives EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Ultomiris (ravulizumab) for Neuromyelitis Optica Spectrum Disorder
Shots:
- The EMA’s CHMP has recommended Ultomiris for marketing authorization in the EU for adult patients with NMOSD who are anti-aquaporin-4 Ab+
- The opinion 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 & showed zero relapses with a median treatment duration of 73wks. (relapse risk reduction 98.6%) & continuing through a median duration of 90wks.
- The safety & tolerability were consistent with prior studies and real-world use with no new safety signals. The regulatory submissions for Ultomiris are under review with multiple health authorities, incl. in the US & Japan
Ref: ultomiris | Image: ultomiris
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