MODERATE IMPACT – Although no detailed data were provided, Alexion/AstraZeneca showed positive topline results for the phase 3 open-label CHAMPION-NMOSD trial for Ultomiris.
- Ultomiris achieved a statistically significant and clinically meaningful reduction in the risk of relapse in adults with AQP4+ NMOSD compared to the 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.
- No relapse was observed in 58 patients over a median treatment duration of 73 weeks.
- The safety and tolerability of Ultomiris in the CHAMPION-NMOSD trial were consistent with previous clinical studies and other approved indications.
- Fifty-six patients are continuing to receive treatment in a long-term extension period, which is ongoing.
Full data will be presented at an upcoming medical meeting.
Another positive data read-out for Ultomiris, which will likely lead to a regulatory submission for Ultomiris in NMOSD. The trial design of the CHAMPION-NMOSD is interesting, since it has an historic placebo arm from the Soliris PREVENT trial. We don’t expect this to be a problem during regulatory submission, since this approach was likely discussed with the FDA before starting this pivotal trial. Approval can be expected in Q3 2023.
Source: AstraZeneca Press Release