Pharmaceutical Executive March 25, 2024
Action marks the first FDA approval of a long-acting treatment for adult patients with neuromyelitis optica spectrum disorder who are positive for the anti-aquaporin-4 antibody.
Alexion, AstraZeneca Rare Disease announced that Ultomiris (ravulizumab-cwvz) has received FDA approval to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who have previously tested positive for the anti-aquaporin-4 (AQP4) antibody. The FDA based the approval on positive data from the CHAMPION-NMOSD Phase III trial, which found that Ultomiris reduced the risk of relapse in patients by 98.6% over a 73-week treatment period. As a part of the trial, Ultomiris was compared to an external placebo arm from the previous Soliris PREVENT clinical trial.1
“Alexion has been at the forefront of innovation in NMOSD, striving...
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