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AstraZeneca Receives EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Ultomiris (ravulizumab) for Neuromyelitis Optica Spectrum Disorder

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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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Senior Editor

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.

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