AstraZeneca: CHMP Recommendes Ultomiris For EU Approval For Neuromyelitis Optica Spectrum Disorde
British drug major AstraZeneca PLC (AZN,AZN.L) announced Monday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has recommended Ultomiris for marketing authorisation in the European Union or EU to treat adults with neuromyelitis optica spectrum disorder or NMOSD who are anti-aquaporin-4 (AQP4) antibody positive (Ab+).
NMOSD is a rare and debilitating autoimmune disease that affects the central nervous system, including the spine and optic nerves.
If authorised, Ultomiris would be the first and only approved long-acting C5 complement inhibitor for the treatment of AQP4 Ab+ NMOSD in the EU.
The company noted that no relapses observed in pivotal trial of first and only long-acting C5 inhibitor, indicating potential to prevent long-term disability due to relapses.
The CHMP based its positive opinion on results from the CHAMPION-NMOSD Phase III trial. In the CHAMPION-NMOSD trial, Ultomiris was compared to an external placebo arm from the pivotal Soliris PREVENT clinical trial.
Ultomiris met the primary endpoint of time to first on-trial relapse as confirmed by an independent adjudication committee. AstraZeneca noted that data showed zero relapses were observed among Ultomiris patients with a median treatment duration of 73 weeks, and continuing through a median duration of 90 weeks.
Overall, the safety and tolerability of Ultomiris were consistent with previous clinical studies and real-world use. No new safety signals were observed.
The company noted that regulatory submissions for Ultomiris for the treatment of NMOSD are also currently under review with multiple health authorities, including in the United States and Japan.
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