- AstraZeneca Plc (NASDAQ: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.
- Price Action: AZN shares are up 2.24% at $68.56 during the market session on the last check Wednesday.
