AstraZeneca's Ultomiris Shows Sustained Improvements In Functional Activities In Neuromuscular Disease

AstraZeneca Plc AZN shared new and prolonged follow-up results from the Phase 3 CHAMPION-MG trial open-label extension (OLE) of Ultomiris (ravulizumab-cwvz) in generalized myasthenia gravis (gMG).
Ultomiris demonstrated long-term efficacy, with improvements in activities of daily living, muscle strength, and quality of life sustained through 60 weeks.
Ultomiris was also well tolerated throughout this analysis.
gMG is a rare, debilitating, chronic, autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness.
Also Read: Roche And AstraZeneca Settle Ultomiris Patent Lawsuit.
Ultomiris demonstrated statistically significant improvements from baseline in functional activity, muscle strength, and quality of life at 60 weeks, including Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score.
Additionally, patients transitioning from placebo (n=83) showed a rapid response at a similar magnitude and time course as those who received Ultomiris during the randomized control period.
The most common adverse events (AEs) were headache (16.6%) and diarrhea (13.6%).
Regulatory submissions for Ultomiris for the treatment of gMG are currently under review with multiple health authorities, including in the U.S., European Union (EU), and Japan.
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