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Recently, AstraZeneca announced the long-term follow-up results of the open-label extension (OLE) phase of the Phase 3 CHAMPION-MG trial.
gMG is a rare, debilitating, chronic autoimmune neuromuscular disease that causes loss of neuromuscular function and severe weakness
It is reported that Ultomiris has been approved to treat 2 rare diseases: paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS)
In the CHAMPION-MG trial, 99.
At 60 weeks of OLE, patients had statistically significant improvements in functional activity, muscle strength, and quality of life measures, including myasthenia gravis activities of daily living (MG-ADL) total, compared to baseline (defined as when Ultomiris treatment was initiated).
In addition, patients who transitioned from placebo (n=83) to Ultomiris showed rapid remissions of a similar magnitude and time course as patients who received Ultomiris during RCP
Specifically, in patients treated with Ultomiris for 60 weeks, the changes from baseline in RCP on multiple scales were as follows:
During the CHAMPION-MG trial OLE, the safety and tolerability profile of Ultomiris was consistent with the known safety profile of Ultomiris observed during RCP and in other approved indications
Reference source: ULTOMIRIS (ravulizumab-cwvz) demonstrated sustained improvements in functional activities and quality of life in adults with generalized myasthenia gravis through 60 weeks
