AstraZeneca announced that the CHMP has recommended marketing authorisation for its Ultomiris® (ravulizumab) to treat patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 antibody positive. If authorised, Ultomiris® would be the first and only approved long-acting C5 complement inhibitor for the treatment of the above condition in the EU.
CHMP based its positive opinion on results from the CHAMPION-NMOSD Phase III trial, in which Ultomiris® was compared to an external placebo arm from the Soliris® PREVENT clinical trial.